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Patients With Advanced or Metastatic Malignant TumorsPhase 1/2NCT07073534

Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors

A Phase 1/2 study testing SHR-1501, Adebrelimab in people with Patients With Advanced or Metastatic Malignant Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site 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 is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHR-1501, Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteChina
Study dates
24 Jul 2025to Dec 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

  • Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in person.
  • Age: 18 to 75 years old (including both ends), gender not limited.
  • Subjects with locally advanced or metastatic solid tumors that have been histologically or cytologically confirmed to be inoperable for radical surgery or radical chemoradiotherapy, whose disease progresses after standard treatment, or who have no standard treatment plan, or are not suitable for standard treatment.
  • According to the efficacy evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion;
  • The ECOG physical condition score is 0 or 1.
  • The expected survival time is more than 3 months;

Who cannot join

  • Symptomatic or active central nervous system (CNS) tumor metastasis;
  • Other malignant tumors within five years before the first use of study drugs;
  • Uncontrolled tumor-related pain judged by the investigator;
  • Severe cardiovascular and cerebrovascular diseases;
  • Significant clinical bleeding symptoms within 3 months before the first study drug, and obvious fresh hemoptysis within 1 month before the first study drug;
  • Uncontrollable pleural effusion and/or ascites judged by the study or pleural effusion and/or ascites requiring intervention within 7 days before the first treatment
Show all 21Show fewer
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-related pneumonia requiring steroid therapy;,or active pneumonia at screening; or other moderate to severe pulmonary diseases that significantly affect pulmonary function;
  • Severe infection within 4 weeks before the start of study treatment
  • History of immunodeficiency
  • Used corticosteroids (>10 mg/day prednisone or equivalent) or other systemic immunosuppressants within 14 days before the first study drug.
  • Patients with active pulmonary tuberculosis infection within 1 year before enrollment as determined by medical history or imaging examination, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment
  • Patients whose adverse events caused by previous treatment have not recovered to ≤CTCAE grade 1
  • Patients whose previous treatment washout does not meet the following requirements: Patients who have received chemotherapy, biological therapy, targeted therapy, immunotherapy, or other unlisted clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug
  • Patients who have experienced CTCAE grade 4 or grade 3 immune-related adverse events lasting for 4 weeks or longer after previous use of immune checkpoint inhibitors, or immune-related adverse events that led to treatment discontinuation, are not eligible for enrollment in this study.
  • Patients who have received >30 Gy chest radiotherapy within 24 weeks before the first use of the study drug, patients who have received >30 Gy non-chest radiotherapy within 4 weeks before the first use of the drug (subjects who have completed brain metastasis radiotherapy 14 days before the first use of the drug can be enrolled), and patients who have received ≤30 Gy within 14 days before the first use of the drug Gy of palliative radiation;
  • Subjects who have undergone surgery on important organs (excluding puncture biopsy) within 4 weeks before the first use of the study drug, have had significant trauma, or need to undergo elective surgery during the trial;
  • Active, known or suspected autoimmune diseases and history of autoimmune diseases.
  • Using attenuated live vaccines within 28 days before the first use of the study drug, or anticipating the need to use attenuated live vaccines during the study treatment;
  • Pregnant or lactating women or female subjects who plan to become pregnant during the study and within 6 months after the last use of the study drug;
  • Those who are known to be allergic to any component or excipient of the study drug; or have a history of severe allergic reactions to other monoclonal antibodies/fusion protein drugs;
  • The investigators judge that the subjects have other factors that may affect the study results or force the termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of trial data.

Trial locations and contacts

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

Fei Qiu contact

+0518-81220121

fei.qiu@hengrui.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Li Zhang

    Recruiting

Other trials in China

About this study

Official title: Phase I/II Clinical Study on the Tolerability, Safety and Efficacy of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors

This study is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.

Being tested
SHR-1501, Adebrelimab
Medical subject headings
Neoplasms

What participants receive

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

  • SHR-1501, AdebrelimabDrug

    the combination of SHR-1501 and Adebrelimab

Study groups in NCT07073534
Study groupRoleWhat they receive
the combination of SHR-1501 and AdebrelimabExperimentalNot described
Receives: Drug: SHR-1501, Adebrelimab

What is being measured

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

  1. Dose-limiting toxicity

    evaluate the safety in the doses escalation

    Measured: 21 Days or 28 days

  2. Maximum tolerated dose or Maximum-administered dose

    evaluate the safety in the doses escalation

    Measured: Approximately 1 years

  3. Recommended Phase 2 dose (RP2D)

    evaluate the safety and curative effect in the doses escalation

    Measured: Approximately 2years.

  4. Objective response rate(ORR)

    Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  5. The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)

    Preliminary safety of the effectiveness of the combination of SHR-1501 and Adebrelimab

    Measured: 21 Days，Approximately 2 years

Secondary outcomes (10)

  1. Maximum concentration (Cmax) of SHR-1501

    To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  2. Time to maximum concentration (Tmax) of SHR-1501

    To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  3. Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501

    To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  4. Steady-state valley concentration (Cmin)of SHR-1501

    To evaluate the pharmacokinetic characteristics of Steady-state valley concentration

    Measured: Approximately 2 years

  5. Accumulation ratio（Rac） of SHR-1501

    To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  6. Anti-drug antibody of SHR-1501

    To evaluate the pharmacokinetic characteristics of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  7. Duration of response(DoR)

    Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  8. Disease control rate （DCR）

    Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  9. Progression free survival （PFS ）

    Preliminary evaluation of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

  10. Overall survival（OS）

    Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab

    Measured: Approximately 2 years

Timeline

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

  1. First posted18 Jul 2025
  2. Study start24 Jul 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
203 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073534
Sponsor's protocol ID
SHR-1501-202
Status last verified
Jul 2025
First submitted
9 Jul 2025
Last updated
22 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 1/2 study testing SHR-1501, Adebrelimab in people with Patients With Advanced or Metastatic Malignant 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 21 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 22 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 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 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 Fei Qiu (+0518-81220121, fei.qiu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: 21 Days or 28 days). The study lists 5 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 NCT07073534.

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 22 Jan 2026.

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