Solid Tumor, AdultPhase 1NCT06462716

A Phase l Study of By101298, an Oral DNA-PK Inhibitor, in Patients With Advanced Solid Tumors

A Phase 1 study testing BY101298 Capsules in people with Solid Tumor, Adult, run by Chengdu Baiyu Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

BY101298 is an innovative DNA-dependent protein kinases (DNA-PK) highly selective small molecule inhibitor. DNA-dependent protein kinases (DNA-PK plays a key role in the NHEJ repair pathway to repair DNA double-strand breaks (DSBs). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumor, Adult
What is being tested?: BY101298 Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteChina
Study dates: 25 Apr 2023to 30 Jun 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients, ≥ 18 and ≤ 75 years of age (inclusive at the time of informed consent).
Diagnostic outcome:
Phase Ia: patients histologically or cytologically diagnosed advanced malignant solid tumors who have failed, cannot tolerate, or refuse prior standard treatment regimens. At least 1 measurable lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Life expectancy ≥ 3 months.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
Adequate organ and bone marrow function. Laboratory tests that meet the following criteria within 7 days prior to the first dose of study treatment (without blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor therapy, renal replacement therapy, etc., within 28 days prior to the screening examination):

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Routine blood test:
Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelets count (PLT) ≥ 100×109/L Hemoglobin (Hb) ≥ 90 g/L
Hepatic function:
Total bilirubin (TBIL) ≤ 1.5×ULN Aspartate aminotransferase (AST) ≤ 2.5×ULN Alanine aminotransferase (ALT) ≤ 2.5×ULN ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN for patients with primary liver cancer, liver metastases, or Gilbert 's syndrome.
Renal function:
Creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula).
Coagulation function:
International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN
Females and males of childbearing potential must agree to use appropriate methods of contraception (hormonal/barrier method or abstinence) during the study and for 3 months after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration.
Understand and be willing to sign written informed consent and be able to follow the study protocol for treatment, visits, and other study procedures.

Who cannot join

1.Treated with DNA-PK inhibitors. 2.Patients who have received systemic chemotherapy, traditional Chinese medicine for anti-tumor indications or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biological therapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug, or those who need to continue receiving these drugs during the study, with the following three exceptions: Receiving nitrosourea or mitomycin C, which needs more than 6 weeks from the last dose.
Receiving extensive radiotherapy (> 30% of bone marrow radiation), which needs more than 8 weeks from the last radiotherapy.
History of palliative radiotherapy for bone metastases, which needs more than 2 weeks from the last radiotherapy.
3.Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study drug and surgery is scheduled during the study period.
4.Brain metastasis (except asymptomatic, stable for more than 4 weeks prior to the first dose and not requiring steroid therapy for at least 4 weeks prior to the first dose, no imaging findings of marked edema around the tumor lesion), presence of meningeal metastasis or brainstem metastasis, or presence of spinal cord compression.
5.History of other malignancy within the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or other carcinomas in situ which have undergone curative treatment and have had no recurrence within 5 years after treatment.

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6.Toxicities from prior antitumor therapy that have not recovered to CTCAE version 5.0 Grade 1 or less, except CTCAE (V5.0) Grade 2 peripheral neurotoxicity and alopecia of any grade.
7.Serious or uncontrolled diseases as assessed by the investigator, including but not limited to: Severe or uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg under standardized antihypertensive regimens), epilepsy, chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson 's disease, active bleeding, uncontrolled infection.
Cognitive dysfunction, history of psychiatric disorders, other uncontrolled concomitant diseases, alcohol dependence, hormone dependence, or drug abuse.
History of immunodeficiency, including HIV antibody positive, other acquired or congenital immunodeficiency disease, or history of organ transplantation.
HBsAg or HBcAb positive, and peripheral blood HBV DNA titer test ≥ 200 IU/mL or ≥ 1000 copies/mL or above the upper limit of normal value at the study site; HCV antibody test positive, and HCV RNA test above the upper limit of normal value at the study site; treponema pallidum-specific antibody positive.
Clinically serious gastrointestinal dysfunction that may compromise drug intake, transport, or absorption. For example, inability to take oral medication, uncontrollable nausea or vomiting, history of massive gastrointestinal resection, history of gastrointestinal ulcer and gastrointestinal bleeding within 6 months prior to the first dose, untreated recurrent diarrhea, untreated stomach disease requiring long-term use of PPI acid suppressants, Crohn 's disease, ulcerative colitis, etc.
Prior thyroid dysfunction or inability to maintain thyroid function within normal limits even with medical therapy.
8.Cardiac dysfunction, including any of the following: Myocardial infarction in past 6 months, heart failure classified as Class II/III/IV according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, and unstable arrhythmia.
Left ventricular ejection fraction LVEF < 50% shown by echocardiography. QT interval corrected using Fridericia 's formula: QTcF > 470 msec (females), QTcF > 450 msec (males).
9.Pregnant (positive pregnancy test prior to dosing) or lactating. 10.History of serious hypersensitivity (e.g., anaphylactic shock) or hypersensitivity to excipients or other ingredients associated with the study drug.
Other factors considered unsuitable for study enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital
Jinan, Shandong, 250117

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BY101298 as Single-agent Therapy/in Combination With Radiotherapy in Patients With Malignant Solid Tumors

Primary objective is to assess the safety and tolerability of BY101298 in patients with advanced malignant solid tumors. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 in patients with advanced malignant solid tumors and to assess the preliminary efficacy of BY101298 in patients with advanced malignant solid tumors.

Conditions: Solid Tumor, Adult
Being tested: BY101298 Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BY101298 CapsulesDrug
An oral DNA-PK Inhibitor

Study groups in NCT06462716
Study group	Role	What they receive
BY101298	Experimental	Dose Escalation: Subjects will receive a starting dose of 50 milligram (mg) of BY1298 as Capsule orally once daily, ascending to 100, 200, 300 and 400 mg. If MTD is not reached at 400 mg, other dosage will be explored. Receives: Drug: BY101298 Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the safety and tolerability of BY101298 in patients with advanced solid tumors
Grade and frequency of adverse events and serious adverse events
Measured: through study completion (an average of 1.5 years)
To assess the maximum tolerated dose (MTD)
Incidence of Dose limiting Toxicities (DLTs)
Measured: through study completion (an average of 1.5 years)

Secondary outcomes (4)

To assess preliminary antitumor activity of BY101298 in patients with advanced solid tumors
ORR
Measured: through study completion (an average of 1.5 years)
To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors
AUC
Measured: through study completion (an average of 1.5 years)
To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors
Cmax
Measured: through study completion (an average of 1.5 years)
To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors
T1/2
Measured: through study completion (an average of 1.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202330 Jun 2025

First posted17 Jun 2024
Study start25 Apr 2023
Primary completion31 Dec 2024
Study completion30 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor, AdultStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06462716
Sponsor's protocol ID: BY1298-I-01
Status last verified: Jun 2024
First submitted: 12 Jun 2024
Last updated: 13 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
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Advanced or Recurrent Solid Tumors Treated With SHetA2
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RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

All Solid Tumor, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BY101298 as Single-agent Therapy/in Combination With Radiotherapy in Patients With Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06462716
Acronym / sponsor ID: BY1298-I-01
Conditions: Solid Tumor, Adult
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (estimated)
Lead sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Apr 2023 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 30 Jun 2025 (estimated)
First posted: 17 Jun 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BY101298	Experimental	Drug: BY101298 CapsulesDose Escalation: Subjects will receive a starting dose of 50 milligram (mg) of BY1298 as Capsule orally once daily, ascending to 100, 200, 300 and 400 mg. If MTD is not reached at 400 mg, other dosage will be explored.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male or female patients, ≥ 18 and ≤ 75 years of age (inclusive at the time of informed consent).
Diagnostic outcome:
Phase Ia: patients histologically or cytologically diagnosed advanced malignant solid tumors who have failed, cannot tolerate, or refuse prior standard treatment regimens. At least 1 measurable lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Life expectancy ≥ 3 months.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.

Key exclusion criteria (17 listed)

1.Treated with DNA-PK inhibitors. 2.Patients who have received systemic chemotherapy, traditional Chinese medicine for anti-tumor indications or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biological therapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug, or those who need to continue receiving these drugs during the study, with the following three exceptions: Receiving nitrosourea or mitomycin C, which needs more than 6 weeks from the last dose.
Receiving extensive radiotherapy (> 30% of bone marrow radiation), which needs more than 8 weeks from the last radiotherapy.
History of palliative radiotherapy for bone metastases, which needs more than 2 weeks from the last radiotherapy.
3.Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study drug and surgery is scheduled during the study period.
4.Brain metastasis (except asymptomatic, stable for more than 4 weeks prior to the first dose and not requiring steroid therapy for at least 4 weeks prior to the first dose, no imaging findings of marked edema around the tumor lesion), presence of meningeal metastasis or brainstem metastasis, or presence of spinal cord compression.

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
BY101298 CapsulesAn oral DNA-PK Inhibitor	Drug	BY101298

Primary outcome

To assess the safety and tolerability of BY101298 in patients with advanced solid tumors
Time frame: through study completion (an average of 1.5 years)
Grade and frequency of adverse events and serious adverse events
To assess the maximum tolerated dose (MTD)
Time frame: through study completion (an average of 1.5 years)
Incidence of Dose limiting Toxicities (DLTs)

4 secondary outcomes

To assess preliminary antitumor activity of BY101298 in patients with advanced solid tumors
Time frame: through study completion (an average of 1.5 years)
To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors
Time frame: through study completion (an average of 1.5 years)
To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors
Time frame: through study completion (an average of 1.5 years)
To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors
Time frame: through study completion (an average of 1.5 years)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.

Related trials for Solid Tumor, Adult

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BY101298 Capsules in people with Solid Tumor, Adult, run by Chengdu Baiyu Pharmaceutical Co., Ltd. at 1 site 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 16 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and tolerability of BY101298 in patients with advanced solid tumors (time frame: through study completion (an average of 1.5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06462716.

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 13 Apr 2025.