Advanced Solid TumorsPhase 1/2NCT06474455
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SHR-9839 for Injection, SHR-A1921 for Injection and SHR-A2009 for Injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-9839 for Injection, SHR-A1921 for Injection and SHR-A2009 for Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jul 2024to Dec 2029
- 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
- Aged 18-75 years old (inclusive), regardless of gender.
- Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance score of 0-1.
- Life expectancy ≥ 12 weeks.
- Adequate bone marrow and organ function.
- Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.
Who cannot join
- Patients with active central nervous system ( CNS ) metastases.
- Spinal cord compression not be cured by surgery or radiotherapy.
- Subjects with uncontrollable tumor-related pain.
- Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
- Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
- Received > 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
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- Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
- Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
- History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
- Serious cardiovascular and cerebrovascular diseases.
- Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
- History of immunodeficiency, including HIV test positive.
- Active hepatitis B or hepatitis C infection.
- History of severe allergic reactions to any component of any study drug to be accepted.
- Known history of alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or lactating women.
- Patients with any active, known or suspected autoimmune disease.
- Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study.
- Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Zhengbo Song
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Qiming Wang
About this study
Official title: A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-9839 for Injection, SHR-A1921 for Injection, SHR-A2009 for Injection, Almonertinib Mesilate Tablets, Pemetrexed Disodium for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-9839 for InjectionDrug
SHR-9839 for injection.
SHR-A1921 for InjectionDrug
SHR-A1921 for injection.
SHR-A2009 for InjectionDrug
SHR-A2009 for injection.
Almonertinib Mesilate TabletsDrug
Almonertinib Mesilate Tablets.
Pemetrexed Disodium for InjectionDrug
Pemetrexed Disodium for Injection.
Carboplatin for injectionDrug
Carboplatin for injection.
Paclitaxel injectionDrug
Paclitaxel injection.
SHR-1316 InjectionDrug
SHR-1316 injection.
SHR-9839 for Injection (sc)Drug
SHR-9839 for Injection (sc).
| Study group | Role | What they receive |
|---|---|---|
| SHR-9839 combined with SHR-A2009 | Experimental | Not described Receives: Drug: SHR-9839 for Injection; Drug: SHR-A2009 for Injection |
| SHR-9839 combined with SHR-A1921 | Experimental | Not described Receives: Drug: SHR-9839 for Injection; Drug: SHR-A1921 for Injection |
| SHR-9839 combined with Pemetrexed + Carboplatin | Experimental | Not described Receives: Drug: SHR-9839 for Injection; Drug: Pemetrexed Disodium for Injection; Drug: Carboplatin for injection |
| SHR-9839 combined with Almonertinib | Experimental | Not described Receives: Drug: SHR-9839 for Injection; Drug: Almonertinib Mesilate Tablets |
| SHR-9839(sc) + SHR-1316 | Experimental | Not described Receives: Drug: SHR-1316 Injection; Drug: SHR-9839 for Injection (sc) |
| SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc) | Experimental | Not described Receives: Drug: Paclitaxel injection; Drug: SHR-1316 Injection; Drug: SHR-9839 for Injection (sc) |
| SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy | Experimental | Not described Receives: Drug: Paclitaxel injection; Drug: SHR-1316 Injection; Drug: SHR-9839 for Injection (sc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) (phase IB)
Measured: 21 days after the first dose was administered to each subject, up to approximately 24 months.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB)
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
Measured: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
Objective Response Rate (ORR) (phase II).
Evaluated using RECIST 1.1.
Measured: The first treatment lasted until disease progression, up to approximately 24 months.
Secondary outcomes (1)
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II)
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
Measured: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start2 Jul 2024
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474455
- Sponsor's protocol ID
- SHR-9839-201
- Status last verified
- May 2026
- First submitted
- 2 Jun 2024
- Last updated
- 11 May 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06474455
- Acronym / sponsor ID
- SHR-9839-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 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.
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SHR-9839 combined with SHR-A2009 | Experimental | Drug: SHR-9839 for Injection, Drug: SHR-A2009 for Injection |
| SHR-9839 combined with SHR-A1921 | Experimental | Drug: SHR-9839 for Injection, Drug: SHR-A1921 for Injection |
| SHR-9839 combined with Pemetrexed + Carboplatin | Experimental | Drug: SHR-9839 for Injection, Drug: Pemetrexed Disodium for Injection, Drug: Carboplatin for injection |
| SHR-9839 combined with Almonertinib | Experimental | Drug: SHR-9839 for Injection, Drug: Almonertinib Mesilate Tablets |
| SHR-9839(sc) + SHR-1316 | Experimental | Drug: SHR-1316 Injection, Drug: SHR-9839 for Injection (sc) |
| SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc) | Experimental | Drug: Paclitaxel injection, Drug: SHR-1316 Injection, Drug: SHR-9839 for Injection (sc) |
| SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy | Experimental | Drug: Paclitaxel injection, Drug: SHR-1316 Injection, Drug: SHR-9839 for Injection (sc) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75 years old (inclusive), regardless of gender.
- Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance score of 0-1.
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (20 listed)
- Patients with active central nervous system ( CNS ) metastases.
- Spinal cord compression not be cured by surgery or radiotherapy.
- Subjects with uncontrollable tumor-related pain.
- Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
- Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| SHR-9839 for InjectionSHR-9839 for injection. | Drug | SHR-9839 combined with Almonertinib, SHR-9839 combined with Pemetrexed + Carboplatin, SHR-9839 combined with SHR-A1921, SHR-9839 combined with SHR-A2009 |
| SHR-A1921 for InjectionSHR-A1921 for injection. | Drug | SHR-9839 combined with SHR-A1921 |
| SHR-A2009 for InjectionSHR-A2009 for injection. | Drug | SHR-9839 combined with SHR-A2009 |
| Almonertinib Mesilate TabletsAlmonertinib Mesilate Tablets. | Drug | SHR-9839 combined with Almonertinib |
| Pemetrexed Disodium for InjectionPemetrexed Disodium for Injection. | Drug | SHR-9839 combined with Pemetrexed + Carboplatin |
| Carboplatin for injectionCarboplatin for injection. | Drug | SHR-9839 combined with Pemetrexed + Carboplatin |
| Paclitaxel injectionPaclitaxel injection. | Drug | SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc), SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy |
| SHR-1316 InjectionSHR-1316 injection. | Drug | SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc), SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy, SHR-9839(sc) + SHR-1316 |
| SHR-9839 for Injection (sc)SHR-9839 for Injection (sc). | Drug | SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc), SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy, SHR-9839(sc) + SHR-1316 |
Primary outcome
Incidence of dose-limiting toxicity (DLT) (phase IB)
Time frame: 21 days after the first dose was administered to each subject, up to approximately 24 months.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB)
Time frame: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
Objective Response Rate (ORR) (phase II).
Time frame: The first treatment lasted until disease progression, up to approximately 24 months.
Evaluated using RECIST 1.1.
1 secondary outcome
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II)
Time frame: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
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 11 May 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 SHR-9839 for Injection, SHR-A1921 for Injection and SHR-A2009 for Injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical 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 7 inclusion and 20 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 11 May 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 Qingkai Zhou (+8618205139261, Qingkai.zhou@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (phase IB) (time frame: 21 days after the first dose was administered to each subject, up to approximately 24 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 11 May 2026.