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

Hengrui Medicine logo

Hengrui Medicine

Status and phase

Enrolling
Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: SHR-7367

Study type

Interventional

Funder types

Industry

Identifiers

NCT05740202
SHR-7367-I-101

Details and patient eligibility

About

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.

Enrollment

182 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Any immunostimulants administered within 4 weeks;
  2. Systemic anti-tumor therapy within 4 weeks;
  3. Any investigational cancer therapy administered within 4 weeks;
  4. Surgical procedures requiring general anesthesia within 4 weeks;
  5. History of autoimmune diseases;
  6. History of immunodeficiency;
  7. Severe infections within 2 weeks prior to the first study treatment;
  8. Clinically significant cardiovascular condition;
  9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
  10. Known history of serious allergic reactions to the investigational product or its main ingredients.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

182 participants in 1 patient group

SHR-7367
Experimental group
Treatment:
Drug: SHR-7367

Trial contacts and locations

1

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Central trial contact

Junshuang diao

Data sourced from clinicaltrials.gov

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