Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: HRS-1167

Study type: Interventional

Funder types: Industry

Identifiers

NCT05473624

HRS-1167-I-101

Details and patient eligibility

About

This study is designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Enrollment: 153 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18；
2. ECOG performance status 0-1;
3. Life expectancy is not less than 12 weeks;
4. Dose escalation and PK expansion part: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists；
5. Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation；
6. At least one target lesion (except maintenance therapy);
7. Adequate organ and marrow function as defined by the protocol.

Exclusion criteria

1. Surgery or chemotherapy within 4 weeks of the first dose of study treatment；
2. Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption；
3. Active HBV/HCV/HIV infection;
4. Untreated and/or uncontrolled brain metastases.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

HRS-1167

Experimental group

Treatment:

Drug: HRS-1167