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Malignant Solid TumorsPhase 2NCT07268040

A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors

A Phase 2 study testing SHR-7787 Injection, SHR-1316 Injection and SHR-4849 Injection in people with Malignant Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Solid Tumors
What is being tested?
SHR-7787 Injection, SHR-1316 Injection and SHR-4849 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
2 sitesChina
Study dates
23 Dec 2025to Dec 2028
Phase
Phase 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

  • Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
  • Patients with histologically or cytologically confirmed unresectable solid tumors;
  • At least one measurable lesion was identified per RECIST 1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
  • Adequate organ functions as defined per protocol;
  • Minimum life expectancy of 3 months.

Who cannot join

  • Patients with known active central nervous system (CNS) metastases;
  • History of other malignancy within the past 5 years, with exceptions defined in the protocol;
  • Patients with uncontrolled cancer pain;
  • Patients with serious cardiovascular and/or cerebrovascular diseases;
  • Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
  • Patients with Severe infections within 4 weeks prior to the first dose;
Show all 12Show fewer
  • Active pulmonary tuberculosis infection;
  • History of immunodeficiency;
  • History of autoimmune diseases;
  • The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
  • Pregnant or nursing women, or planned to become pregnant during the study period;
  • Known allergic to any component of investigational drugs.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xianhua Qiu contact

+86-0518-82342973

xianhua.qiu@hengrui.com

China2 sites, 2 recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Shengxiang Ren, +86-021-65115006 ext. 3051, arry_ren@126.com

    Shengxiang Ren

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    Qian Chu, +86-027-83663147, qchu@hust.edu.cn

    Qian Chu

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors

This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.

Being tested
SHR-7787 Injection, SHR-1316 Injection, SHR-4849 Injection, Etoposide injection, Carboplatin injection

What participants receive

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

  • SHR-7787 InjectionDrug

    SHR-7787 Injection.

  • SHR-1316 InjectionDrug

    SHR-1316 Injection.

  • SHR-4849 InjectionDrug

    SHR-4849 Injection.

  • Etoposide injectionDrug

    Etoposide Injection.

  • Carboplatin injectionDrug

    Carboplatin Injection.

  • Cisplatin injectionDrug

    Cisplatin Injection.

  • BP102 InjectionDrug

    BP102 Injection.

Study groups in NCT07268040
Study groupRoleWhat they receive
SHR-7787 combined with SHR-1316ExperimentalSHR-7787 injection combined with SHR-1316 injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 Injection
SHR-7787 combined with SHR-4849ExperimentalSHR-7787 injection combined with SHR-4849 injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-4849 Injection
SHR-7787 combined with etoposide and carboplatin/cisplatinExperimentalSHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
Receives: Drug: SHR-7787 Injection; Drug: Etoposide injection; Drug: Carboplatin injection; Drug: Cisplatin injection
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatinExperimentalSHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 Injection; Drug: Etoposide injection; Drug: Carboplatin injection; Drug: Cisplatin injection
SHR-7787 combined with SHR-4849 and SHR-1316ExperimentalSHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 Injection; Drug: SHR-4849 Injection
SHR-7787 combined with SHR-1316 and BP102ExperimentalSHR-7787 injection combined with SHR-1316 and BP102 injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 Injection; Drug: BP102 Injection
SHR-7787 combined with SHR-4849 and BP102ExperimentalSHR-7787 injection combined with SHR-4849 and BP102 injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-4849 Injection; Drug: BP102 Injection
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatinExperimentalSHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Receives: Drug: SHR-7787 Injection; Drug: SHR-1316 Injection; Drug: SHR-4849 Injection; Drug: Carboplatin injection; Drug: Cisplatin injection

What is being measured

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

  1. The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)

    Measured: Expected to be two years after the start of the study.

  2. Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)

    Measured: About 1 year after study initiation.

  3. Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)

    Measured: About 1 year after study initiation.

  4. Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)

    Measured: About 1 year after study initiation.

  5. Objective response rate (ORR) (stage II)

    Measured: Expected to be two years after the start of the study.

  6. Progress Free Survival (FPS) (stage II)

    Measured: Expected to be two years after the start of the study.

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Measured: About 1 year.

  2. Duration of Response (DoR)

    Measured: About 1 year.

  3. Disease Control Rate (DCR)

    Measured: About 1 year.

  4. Progress Free Survival (PFS)

    Measured: About 1 year.

  5. Overall Survival (OS)

    Measured: About 1 year.

Timeline

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

  1. First posted5 Dec 2025
  2. Study start23 Dec 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07268040
Sponsor's protocol ID
SHR-7787-201
Status last verified
Jan 2026
First submitted
24 Nov 2025
Last updated
12 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-7787 Injection, SHR-1316 Injection and SHR-4849 Injection in people with Malignant 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 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 12 Jan 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 phase mean?

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 Xianhua Qiu (+86-0518-82342973, xianhua.qiu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Recommended phase II dose of SHR-7787 injection monotherapy (stage I) (time frame: Expected to be two years after the start of the study.). The study lists 6 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 NCT07268040.

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 12 Jan 2026.

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