Solid TumorsPhase 1NCT06783569
A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors
A Phase 1 study testing JR8603 in people with Solid Tumors and Gastric Cancer, run by JiaRay Group at 2 sites in China.
Trial summary
The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Gastric Cancer, Esophagogastric Juction Cancer
- What is being tested?
- JR8603
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2024to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:
- ≥18 years of age.
- Histologically confirmed, locally advanced, or metastatic solid tumor which has progressed on, or patients intolerant to, all standard therapy, or no standard therapy available, or it is documented that the therapy is refused by the patient.
- Measurable disease per RECIST v1.1.
- Life expectancy ≥3 months.
- Adequate organ and bone marrow function defined by:
Show all 50Show fewer
- Absolute neutrophil count (ANC) ≥1.5 × 109/L (≥1500/mm3)
- Platelet count ≥100 × 109/L (≥100,000/mm3) (no platelet transfusion within 14 days prior to enrollment)
- Total bilirubin ≤1.5 × upper limit of normal (ULN), unless known Gilbert syndrome (≤3 × ULN) has been diagnosed
- AST and ALT ≤2.5 × ULN or ≤5 × ULN for patients with known liver metastases
- Estimated creatinine clearance by the Cockcroft-Gault or estimated glomerular filtration rate (eGFR) of ≥60 mL/min
- International Normalized Ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. If a patient is receiving anticoagulant therapy, PT and aPTT must be within therapeutic range of intended use of anticoagulants
- Patients with treated, stable central nervous system (CNS) metastases (including leptomeningeal carcinomatosis) are allowed if there is no evidence of progression for at least 4 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging.
- Resolution of any clinically significant toxic effects of prior therapy to Grade ≤1 according to the NCI CTCAE v5.0 (exception of alopecia and Grade 2 peripheral neuropathy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Willingness of men and women of reproductive potential to observe conventional and effective birth control methods with failure rates of <1% for the duration of treatment and for at least 6 months for women and at least 3 months for men following the last dose of study treatment (this must include a barrier method such as condom or diaphragm with spermicidal gel). Women of reproductive potential are defined as following menarche and who are not postmenopausal (and 2 years of nontherapy-induced amenorrhea or surgically sterile). For male patients with a nonpregnant female partner of childbearing potential and a woman of childbearing potential, 1 of the following highly effective birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended:
- Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
- Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion/ligation
- Vasectomized partner
- Sexual abstinence Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Birth control methods unacceptable for this study include the following:
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- Periodic abstinence (calendar, symptothermal, or post-ovulation methods)
- Withdrawal (coitus interruptus)
- Spermicide only
- Lactational amenorrhea method Egg and sperm donation or banking is prohibited during the duration of participation on this protocol and for 90 days after the last dose of study drug. 10. A negative serum pregnancy test at screening and a negative (serum or urine) pregnancy test within 72 hours before the first dose of study drug (female patients of childbearing potential only). If the urine test is positive or cannot be confirmed negative, a serum pregnancy test will be required and must be negative for the patient to be eligible.
- 11. Willing and able to provide informed consent and comply with protocol requirements for the duration of the study.
- Specific Inclusion Criteria for Expansion Cohorts:
- To be eligible during the dose expansion part of the study, patients must meet 1 of the following 2 criteria:
- Expansion Cohort 1: Documented locally advanced or metastatic gastric or
- EGJ cancer which has progressed on or after standard therapy or patient is intolerant to standard therapy or patient refuses therapy. Standard therapy options are described in (Wang,2024):
- Prior systemic standard therapy for patients with HER2-positive gastric or EGJ cancer should include trastuzumab plus chemotherapy (fluorouracil plus platinum), mono-chemotherapy (eg., paclitaxel, docetaxel, irinotecan), and other monotherapy (eg., VEGF targeted agents, anti-PD-1 or PD-L1).
- Prior system standard therapy for patients with HER2-negative gastric or EGJ cancer should include fluorouracil plus platinum or in combination with anti-PD-1, mono-chemotherapy (eg., paclitaxel, docetaxel, irinotecan) and VEGF targeted therapy.
- Expansion Cohort 2: Documented locally advanced or metastatic colorectal cancer which has progressed on or after standard therapy or patient is intolerant to standard therapy, or patient refuses therapy. Standard treatment options are described in (Association NHCOTPROCSOOCM,2023):
- Prior systemic standard therapy for patients with MMR-deficient (dMMR)/microsatellite instability-high (MSI-H): pembrolizumab for 1st line therapy, no standard therapy for 2nd and 3rd line therapy.
- Prior system standard therapy for patients with microsatellite stability (MSS) or microsatellite instability-low (MSI-L)/proficient mismatch repair (pMMR), RAS and BRAF wild-type (WT) should include cetuximab or bevacizumab monotherapy or in combination with FOLFOX/FOLFIRI/CAPEOX, and monotherapy (eg., regorafenib, fruquintinib, trifluridine tipiracil).
- Prior system standard therapy for patients with MSS or MSI-L/pMMR, RAS and BRAF mutation: should include bevacizumab monotherapy or in combination with FOLFIRI, and monotherapy (eg., regorafenib, fruquintinib, trifluridine tipiracil).
- Exclusion Criteria Patients who meet any of the following exclusion criteria will be excluded from participation in the study:
- Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.
- Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.
- Major surgery within 3 weeks prior to start of study drug treatment.
- Radiation therapy within 4 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study drug treatment). Patients must have recovered from all acute radiotherapy-related toxicities.
- Severe or unstable cardiac conditions including, but not limited to, congestive heart failure (New York Heart Association Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled cardiac arrhythmia requiring medication (Grade ≥2, according to NCI CTCAE v5.0), myocardial infarction within 6 months prior to starting study drug treatment, congenital long QT syndrome or QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 msec at screening, and any other significant or unstable concurrent cardiac illness.
- Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.
- Has a history of another active malignancy (a second cancer) within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, present a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Active infection requiring systemic therapy (including asymptomatic infections with positive virus titers and the Investigator's judgment that worsening of the condition is likely with study drug or the condition will impair or prohibit a patient's participation in the study).
- Known human immunodeficiency virus, hepatitis B virus (HBV) (i.e., hepatitis B surface antigen positive), or hepatitis C virus (HCV) (i.e., detectable HCV ribonucleic acid [RNA]). Note: Patients with a prior history of treated HBV infection who are antigen negative, patients with a prior history of treated HCV infection who are HCV RNA undetectable, or patients with HIV who are on stable anti-retroviral therapy and have an undetectable viral load may be enrolled.
- Pregnant (or intending to become pregnant) or breastfeeding.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heiljiang Province, 150040
Lingling Jiang, +86 159 9436 7560, lingling.jiang3@pharmaron.com
Yanqiao Zhang, Doctorate
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Jingdong Zhang, MD
About this study
Official title: A First-in-Human, Open-Label, Dose Escalation and Expansion Study of JR8603 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.
Read the detailed description
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability and preliminary efficacy of JR8603 in patients with locally advanced or metastatic solid tumors who have progressed after or are intolerant to standard therapies. The study will include a Dose Escalation Part and a Dose Expansion Part. JR8603 will be administered as a short IV infusion on Days 1, 8, and 15 of continuous 28-day cycles. Safety and tolerability of JR8603 will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. All patients will be assessed for response using Response Criteria for Evaluation in Solid Tumors (RECIST) v1.1, with computed tomography (CT) or magnetic resonance imaging (MRI) occurring at screening within 28 days of first dose, then every 8 weeks (±7 days) after Cycle 1 Day 1 (C1D1) for the first year and every 12 weeks (±7 days) thereafter. Serial blood samples for determination of PK will be collected.
- Being tested
- JR8603
- Keywords
- locally advanced solid tumors, metastatic solid tumors, intolerant to standard therapies, Mitomycin C
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JR8603Drug
IV infusion on Days 1, 8, and 15 of continuous 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Escalation Cohort - Dose Level -1 | Experimental | Dose Level -1: 1.7mg/m2. A Dose Level -1 cohort will be introduced if a dose reduction to a lower level is required. Receives: Drug: JR8603 |
| Escalation Cohort - Dose Level 1 | Experimental | Dose Level 1: 3.3mg/m2.
For Dose Levels 1 and 2, a single patient will be enrolled per dose level. If the patient in Dose Level 1 does not experience a Grade ≥2 adverse event (AE) that is not clearly attributed to an extraneous cause, such as the patient's underlying disease, other medical conditions, or concomitant medications or procedures during the dose-limiting toxicity (DLT) period, then Dose Level 2 will also be a single patient.
If the patient in Dose Level 1 experiences a Grade ≥2 AE during the DLT period, then 2 additional patients will be added to Dose Level 1 and the remainder of the study will use 3+3 design rules. Receives: Drug: JR8603 |
| Escalation Cohort - Dose Level 2 | Experimental | Dose Level 2: 7.0mg/m2. If Dose Level 2 is qualified to be a single patient, and the patient does not experience a Grade ≥2 AE during the DLT period, then Dose Level 3 will proceed and the study, thereafter, will utilize 3+3 design rules.
If the patient in Dose Level 2 experiences a Grade ≥2 AE during the DLT period, then 2 additional patients will be enrolled in Dose Level 2 and evaluated using 3+3 design rules. Receives: Drug: JR8603 |
| Escalation Cohort - Dose Level 3 | Experimental | Dose Level 3: 14.0mg/m2. From Dose Level 3 and thereafter, dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 3 patients complete the DLT period with no DLTs, that dose level of JR8603 will be deemed safe, and another 3 patients will be treated at the next higher dose level.
If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603.
If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. Receives: Drug: JR8603 |
| Escalation Cohort - Dose Level 4 | Experimental | Dose Level 4: 21.0mg/m2. Dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 3 patients complete the DLT period with no DLTs, that dose level of JR8603 will be deemed safe, and another 3 patients will be treated at the next higher dose level.
If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603.
If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. Receives: Drug: JR8603 |
| Escalation Cohort - Dose Level 5 | Experimental | Dose Level 5: 28.0mg/m2. Dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 3 patients complete the DLT period with no DLTs, that dose level of JR8603 will be deemed safe, and another 3 patients will be treated at the next higher dose level.
If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603.
If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. Receives: Drug: JR8603 |
| Escalation Cohort - Dose Level 6 | Experimental | Dose Level 6: 35.0mg/m2. Dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level.
If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603.
If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. Receives: Drug: JR8603 |
| Expansion Cohort 1 | Experimental | Not described Receives: Drug: JR8603 |
| Expansion Cohort 2 | Experimental | Not described Receives: Drug: JR8603 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (Including Serious Adverse Events)
The severity of all AEs will be graded according to the NCI CTCAE v5.0 criteria.
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Dose-Limiting Toxicity (DLT)
Incidence of DLTs
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Maximum tolerated dose (MTD)
Evaluated based on DLT-Evaluable patients in part 1 Dose Escalation
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Dose Expansion - to assess preliminary evidence of efficacy for each cohort
Measured by Overall Response Rate (ORR) as defined by RECIST v1.1.
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Secondary outcomes (7)
Overall Response Rate (ORR)
Defined as the proportion of patients with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Assess Plasma concentrations and relevant PK parameters for JR8603 and the active metabolite (mitomycin C)
Will be assessed based on blood samples collected from patients during the study.
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Time to Response (TTR)
Defined as the time from the date of the first dose to the date at which criteria are first met for Complete Response (CR) or Partial Response (PR) per RECIST v1.1.
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Duration of Response (DOR)
Defined as the time from the start of the first response (CR or PR) to the first occurrence of progressive disease per RECIST v1.1 or death due to any cause
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Disease Control Rate (DCR)
Defined as the proportion of patients whose best overall response is a CR, PR, or stable disease (SD)
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Progression-free survival (PFS)
Defined as the time from the first dose of JR8603 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Overall survival (OS)
Defined as the time from the date of the first dose of study drug to the date of death due to any cause.
Measured: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start31 Dec 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1: Dose Escalation- will consist of accelerated titration followed by traditional 3+3 design. The accelerated titration portion may consist of up to 3 patients in the first 2 dose levels and the 3+3 ascending dose escalation portion will consist of 3 to 6 patients per dose level. Part 2: Dose Expansion- each cohort will be enrolled independently following a Simon's 2-Stage optimal design. In the first stage, 10 evaluable patients will be enrolled. If there is only 1 or no response in these 10 patients, the cohort will be stopped. Otherwise, 19 additional evaluable patients will be accrued to that cohort for a total of 29 evaluable patients.
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JiaRay Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783569
- Sponsor's protocol ID
- JR8603-9101
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-Label, Dose Escalation and Expansion Study of JR8603 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06783569
- Acronym / sponsor ID
- JR8603-9101
- Keywords
- locally advanced solid tumors, metastatic solid tumors, intolerant to standard therapies, Mitomycin C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- JiaRay GroupIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.
Detailed description
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability and preliminary efficacy of JR8603 in patients with locally advanced or metastatic solid tumors who have progressed after or are intolerant to standard therapies. The study will include a Dose Escalation Part and a Dose Expansion Part. JR8603 will be administered as a short IV infusion on Days 1, 8, and 15 of continuous 28-day cycles. Safety and tolerability of JR8603 will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. All patients will be assessed for response using Response Criteria for Evaluation in Solid Tumors (RECIST) v1.1, with computed tomography (CT) or magnetic resonance imaging (MRI) occurring at screening within 28 days of first dose, then every 8 weeks (±7 days) after Cycle 1 Day 1 (C1D1) for the first year and every 12 weeks (±7 days) thereafter. Serial blood samples for determination of PK will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Part 1: Dose Escalation- will consist of accelerated titration followed by traditional 3+3 design. The accelerated titration portion may consist of up to 3 patients in the first 2 dose levels and the 3+3 ascending dose escalation portion will consist of 3 to 6 patients per dose level. Part 2: Dose Expansion- each cohort will be enrolled independently following a Simon's 2-Stage optimal design. In the first stage, 10 evaluable patients will be enrolled. If there is only 1 or no response in these 10 patients, the cohort will be stopped. Otherwise, 19 additional evaluable patients will be accrued to that cohort for a total of 29 evaluable patients.
| Arm | Type | Receives |
|---|---|---|
| Escalation Cohort - Dose Level -1 | Experimental | Drug: JR8603Dose Level -1: 1.7mg/m2. A Dose Level -1 cohort will be introduced if a dose reduction to a lower level is required. |
| Escalation Cohort - Dose Level 1 | Experimental | Drug: JR8603Dose Level 1: 3.3mg/m2. For Dose Levels 1 and 2, a single patient will be enrolled per dose level. If the patient in Dose Level 1 does not experience a Grade ≥2 adverse event (AE) that is not clearly attributed to an extraneous cause, such as the patient's underlying disease, other medical conditions, or concomitant medications or procedures during the dose-limiting toxicity (DLT) period, then Dose Level 2 will also be a single patient. If the patient in Dose Level 1 experiences a Grade ≥2 AE during the DLT period, then 2 additional patients will be added to Dose Level 1 and the remainder of the study will use 3+3 design rules. |
| Escalation Cohort - Dose Level 2 | Experimental | Drug: JR8603Dose Level 2: 7.0mg/m2. If Dose Level 2 is qualified to be a single patient, and the patient does not experience a Grade ≥2 AE during the DLT period, then Dose Level 3 will proceed and the study, thereafter, will utilize 3+3 design rules. If the patient in Dose Level 2 experiences a Grade ≥2 AE during the DLT period, then 2 additional patients will be enrolled in Dose Level 2 and evaluated using 3+3 design rules. |
| Escalation Cohort - Dose Level 3 | Experimental | Drug: JR8603Dose Level 3: 14.0mg/m2. From Dose Level 3 and thereafter, dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 3 patients complete the DLT period with no DLTs, that dose level of JR8603 will be deemed safe, and another 3 patients will be treated at the next higher dose level. If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603. If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. |
| Escalation Cohort - Dose Level 4 | Experimental | Drug: JR8603Dose Level 4: 21.0mg/m2. Dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 3 patients complete the DLT period with no DLTs, that dose level of JR8603 will be deemed safe, and another 3 patients will be treated at the next higher dose level. If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603. If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. |
| Escalation Cohort - Dose Level 5 | Experimental | Drug: JR8603Dose Level 5: 28.0mg/m2. Dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 3 patients complete the DLT period with no DLTs, that dose level of JR8603 will be deemed safe, and another 3 patients will be treated at the next higher dose level. If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603. If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. |
| Escalation Cohort - Dose Level 6 | Experimental | Drug: JR8603Dose Level 6: 35.0mg/m2. Dose escalation will follow 3+3 design rules with 3 patients enrolled in each dose level. If 1 of the first 3 patients experiences a DLT, 3 more patients will be treated at the same dose level of JR8603. If 2 or more of the 3 to 6 patients in any dose level experience a DLT, dosing will stop at that level. |
| Expansion Cohort 1 | Experimental | Drug: JR8603 |
| Expansion Cohort 2 | Experimental | Drug: JR8603 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (50 listed)
- Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:
- ≥18 years of age.
- Histologically confirmed, locally advanced, or metastatic solid tumor which has progressed on, or patients intolerant to, all standard therapy, or no standard therapy available, or it is documented that the therapy is refused by the patient.
- Measurable disease per RECIST v1.1.
- Life expectancy ≥3 months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JR8603IV infusion on Days 1, 8, and 15 of continuous 28-day cycles | Drug | Escalation Cohort - Dose Level -1, Escalation Cohort - Dose Level 1, Escalation Cohort - Dose Level 2, Escalation Cohort - Dose Level 3, Escalation Cohort - Dose Level 4, Escalation Cohort - Dose Level 5, Escalation Cohort - Dose Level 6, Expansion Cohort 1, Expansion Cohort 2 |
Primary outcome
Adverse Events (Including Serious Adverse Events)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
The severity of all AEs will be graded according to the NCI CTCAE v5.0 criteria.
Dose-Limiting Toxicity (DLT)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Incidence of DLTs
Maximum tolerated dose (MTD)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Evaluated based on DLT-Evaluable patients in part 1 Dose Escalation
Dose Expansion - to assess preliminary evidence of efficacy for each cohort
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Measured by Overall Response Rate (ORR) as defined by RECIST v1.1.
7 secondary outcomes
Overall Response Rate (ORR)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Assess Plasma concentrations and relevant PK parameters for JR8603 and the active metabolite (mitomycin C)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Time to Response (TTR)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Duration of Response (DOR)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Disease Control Rate (DCR)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Progression-free survival (PFS)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Overall survival (OS)
Time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JR8603 in people with Solid Tumors and Gastric Cancer, run by JiaRay Group at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sam Chu (760-351-6988, samchu@jiaraygroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (Including Serious Adverse Events) (time frame: From study drug administration until 28 (±7) days after the last dose of study drug, up to approximately 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.