Advanced Solid TumorsPhase 1NCT05740202

A Trial of SHR-7367 in Subjects With Advanced Solid Tumors

A Phase 1 study testing SHR-7367 in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects 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-7367
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteChina
Study dates: 6 Mar 2023to 4 Aug 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

Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
Histopathologically or cytologically documented advanced or metastatic malignancies;
At least 1 measurable lesion conforming to RECIST 1.1 criteria;
An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
Female and male patients of reproductive potential must agree to use highly effective contraception.

Who cannot join

Any immunostimulants administered within 4 weeks;
Systemic anti-tumor therapy within 4 weeks;
Any investigational cancer therapy administered within 4 weeks;
Surgical procedures requiring general anesthesia within 4 weeks;
History of autoimmune diseases;
History of immunodeficiency;

Show all 10Show fewer

Severe infections within 2 weeks prior to the first study treatment;
Clinically significant cardiovascular condition;
Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
Known history of serious allergic reactions to the investigational product or its main ingredients.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.

Conditions: Advanced Solid Tumors
Being tested: SHR-7367

What participants receive

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

SHR-7367Drug
The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.

Study groups in NCT05740202
Study group	Role	What they receive
SHR-7367	Experimental	Not described Receives: Drug: SHR-7367

What is being measured

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

Dose-limiting toxicities (DLTs)
Number of participants with DLTs
Measured: Up to 3 weeks
Recommended phase II dose
The Recommended phase II dose of SHR-7367 injection
Measured: first dose of study medication up to 21 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: Up to 12 months

Secondary outcomes (14)

Tumor response using RECIST 1.1
Measured: From first dose to disease progression or death, whichever comes first, up to 12 months
peak time (Tmax)
Measured: Up to 12 months
peak concentration (Cmax)
Measured: Up to 12 months
area under curve from 0 to the last measurable concentration time point t (AUC0-t),
Measured: Up to 12 months
area under curve from 0 to infinity (AUC0-∞)
Measured: Up to 12 months
elimination half-life (t1/2)
Measured: Up to 12 months
clearance rate (CL)
Measured: Up to 12 months
steady-state apparent volume of distribution (Vss)
Measured: Up to 12 months
steady-state peak concentration (Cmax, ss)
Measured: Up to 12 months
steady-state valley concentration (Ctrough, ss)
Measured: Up to 12 months
accumulation ratio (Rac)
Measured: Up to 12 months
percentage of activated B lymphocyte subsets in peripheral blood
Measured: Up to 12 months
Immunogenicity index: drug-resistant antibody (ADA)
Measured: Up to 12 months
Efficacy endpoints: Objective response rate (ORR)
Measured: Up to 12 months

Timeline

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

6 Mar 20234 Aug 2025

First posted22 Feb 2023
Study start6 Mar 2023
Primary completion4 Aug 2025
Study completion4 Aug 2025

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05740202
Sponsor's protocol ID: SHR-7367-I-101
Status last verified: Jul 2026
First submitted: 28 Jan 2023
Last updated: 16 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05740202
Acronym / sponsor ID: SHR-7367-I-101
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Mar 2023 (actual)
Primary completion: 4 Aug 2025 (actual)
Study completion: 4 Aug 2025 (actual)
First posted: 22 Feb 2023 (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 is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.

Arm	Type	Receives
SHR-7367	Experimental	Drug: SHR-7367

Who may qualify

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

Key inclusion criteria (6 listed)

Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
Histopathologically or cytologically documented advanced or metastatic malignancies;
At least 1 measurable lesion conforming to RECIST 1.1 criteria;
An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;

Key exclusion criteria (10 listed)

Any immunostimulants administered within 4 weeks;
Systemic anti-tumor therapy within 4 weeks;
Any investigational cancer therapy administered within 4 weeks;
Surgical procedures requiring general anesthesia within 4 weeks;
History of autoimmune diseases;

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-7367The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.	Drug	SHR-7367

Primary outcome

Dose-limiting toxicities (DLTs)
Time frame: Up to 3 weeks
Number of participants with DLTs
Recommended phase II dose
Time frame: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-7367 injection
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Up to 12 months
• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

14 secondary outcomes

Tumor response using RECIST 1.1
Time frame: From first dose to disease progression or death, whichever comes first, up to 12 months
peak time (Tmax)
Time frame: Up to 12 months
peak concentration (Cmax)
Time frame: Up to 12 months
area under curve from 0 to the last measurable concentration time point t (AUC0-t),
Time frame: Up to 12 months
area under curve from 0 to infinity (AUC0-∞)
Time frame: Up to 12 months
elimination half-life (t1/2)
Time frame: Up to 12 months
clearance rate (CL)
Time frame: Up to 12 months
steady-state apparent volume of distribution (Vss)
Time frame: Up to 12 months
steady-state peak concentration (Cmax, ss)
Time frame: Up to 12 months
steady-state valley concentration (Ctrough, ss)
Time frame: Up to 12 months
accumulation ratio (Rac)
Time frame: Up to 12 months
percentage of activated B lymphocyte subsets in peripheral blood
Time frame: Up to 12 months
Immunogenicity index: drug-resistant antibody (ADA)
Time frame: Up to 12 months
Efficacy endpoints: Objective response rate (ORR)
Time frame: Up to 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Individual participant dataSharing planned: Undecided

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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 SHR-7367 in people with Advanced Solid Tumors, run by Shanghai Hengrui 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 16 Jul 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-limiting toxicities (DLTs) (time frame: Up to 3 weeks). 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?

On the ClinicalTrials.gov record for NCT05740202.

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 16 Jul 2026.