Malignant Solid TumorPhase 1/2NCT07136142
A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
A Phase 1/2 study testing FH-006 for Injection, SHR-1316 Injection and Paclitaxel for Injection (Albumin-Bound) in people with Malignant Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- FH-006 for Injection, SHR-1316 Injection and Paclitaxel for Injection (Albumin-Bound)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 23 Sep 2025to Feb 2027
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.
- Patients with unresectable recurrent or metastatic solid tumors.
- There is at least one lesion that could be measured.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Adequate organ functions as defined.
- Life expectancy ≥ 3 months.
Who cannot join
- Patients with known active central nervous system (CNS) metastases.
- Subjects who had other malignancy in five years before the first dose.
- Patients with tumor-related pain that can not be controlled as determined.
- Patients with serious cardiovascular and cerebrovascular diseases.
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
- Patients with severe infections.
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- History of immunodeficiency.
- History of autoimmune diseases.
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy.
- Active infection.
- Pregnant or nursing women.
- Known history of serious allergic reactions to the investigational product or its main ingredients.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Kuaile Zhao, +86-021-64175590, kuaile_z@fudan.edu.cn
Kuaile Zhao
- Recruiting
Tianjin Medical Unversity Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300181
Jihui Hao, +86-022-23340123, haojihui@tjmuch.com
Jihui Hao
About this study
Official title: A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors
This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.
- Conditions
- Malignant Solid Tumor
- Being tested
- FH-006 for Injection, SHR-1316 Injection, Paclitaxel for Injection (Albumin-Bound)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FH-006 for InjectionDrug
FH-006 for injection.
SHR-1316 InjectionDrug
SHR-1316 Injection.
Paclitaxel for Injection (Albumin-Bound)Drug
Paclitaxel for Injection (Albumin-Bound).
| Study group | Role | What they receive |
|---|---|---|
| FH-006 Group | Experimental | Firstly, FH-006 for injection monotherapy should be conducted for some tumors. Then FH-006 in combination with other anti-cancer treatment would be conduction for the specific tumor, including SHR-1316 injection with or without Albumin-bound paclitaxel. Receives: Drug: FH-006 for Injection; Drug: SHR-1316 Injection; Drug: Paclitaxel for Injection (Albumin-Bound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors.
Measured: Assessed up to 6 months.
Recommended Phase II dose (RP2D)
Measured: From the first dose of study medication up to 28 days.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs)
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks.
Secondary outcomes (6)
Time to maximum concentration (Tmax)
Measured: Up to 2 years.
Maximum concentration (Cmax)
Measured: Up to 2 years.
Terminal half-life (t1/2)
Measured: Up to 2 years.
Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t)
Measured: Up to 2 years.
Adverse events (AEs)
Measured: Up to 24 weeks.
Serious adverse events (SAEs)
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start23 Sep 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- FH-006 for injection monotherapy, or in combination with other anti-cancer therapy.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136142
- Sponsor's protocol ID
- FH-006-102
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07136142
- Acronym / sponsor ID
- FH-006-102
- Conditions
- Malignant Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Aug 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.
This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- FH-006 for injection monotherapy, or in combination with other anti-cancer therapy.
| Arm | Type | Receives |
|---|---|---|
| FH-006 Group | Experimental | Drug: FH-006 for Injection, Drug: SHR-1316 Injection, Drug: Paclitaxel for Injection (Albumin-Bound)Firstly, FH-006 for injection monotherapy should be conducted for some tumors. Then FH-006 in combination with other anti-cancer treatment would be conduction for the specific tumor, including SHR-1316 injection with or without Albumin-bound paclitaxel. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.
- Patients with unresectable recurrent or metastatic solid tumors.
- There is at least one lesion that could be measured.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Adequate organ functions as defined.
Key exclusion criteria (12 listed)
- Patients with known active central nervous system (CNS) metastases.
- Subjects who had other malignancy in five years before the first dose.
- Patients with tumor-related pain that can not be controlled as determined.
- Patients with serious cardiovascular and cerebrovascular diseases.
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
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 |
|---|---|---|
| FH-006 for InjectionFH-006 for injection. | Drug | FH-006 Group |
| SHR-1316 InjectionSHR-1316 Injection. | Drug | FH-006 Group |
| Paclitaxel for Injection (Albumin-Bound)Paclitaxel for Injection (Albumin-Bound). | Drug | FH-006 Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: Assessed up to 6 months.
ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors.
Recommended Phase II dose (RP2D)
Time frame: From the first dose of study medication up to 28 days.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs)
Time frame: From signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
6 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Up to 2 years.
Maximum concentration (Cmax)
Time frame: Up to 2 years.
Terminal half-life (t1/2)
Time frame: Up to 2 years.
Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t)
Time frame: Up to 2 years.
Adverse events (AEs)
Time frame: Up to 24 weeks.
Serious adverse events (SAEs)
Time frame: Up to 24 weeks.
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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 1/2 study testing FH-006 for Injection, SHR-1316 Injection and Paclitaxel for Injection (Albumin-Bound) in people with Malignant Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. 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 6 inclusion and 12 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 23 Sep 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhenqun Lu (+86-0518-81220121, zhenqun.lu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Assessed up to 6 months.). The study lists 3 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 23 Sep 2026.