A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies

Hengrui Medicine

Status and phase: Terminated; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: HRS2300; Drug: HRS2300、 SHR-1316; Drug: HRS2300、SHR-1701; Drug: HRS2300、trametinib; Drug: HRS2300、Almonertinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05048134

HRS2300-I-101

Details and patient eligibility

About

The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-75 years old，Male or female;
2. Patients with pathologically confirmed advanced solid tumors who did not respond to standard treatment, did not tolerate standard treatment, or were determined by the investigator to be unsuitable for standard treatment;
3. ECOG PS score of 0-1;
4. Life expectancy of ≥3 months;
5. Able and willing to provide a written informed consent.

Exclusion criteria

1. Receiving chemotherapy, targeted therapy, immunotherapy, radical radiotherapy or surgical treatment for less than 4 weeks before study therapy (excluding tyrosine kinase inhibitors or other small molecule targeted drugs < 2 weeks); Four weeks prior to the start of study treatment (patients who have entered the follow-up period measured by the time of last use of the experimental drug or device) were enrolled in another clinical study;
2. Drugs that affect the activity of metabolic enzyme CYP3A have been used in the past, and the eluting period from the end time to the first administration in this study is within 5 half-lives;
3. Patients with active TB within 1 year prior to the start of drug therapy or with a history of active TB infection more than 1 year prior to the start of drug therapy without proper treatment were studied;
4. Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 5 patient groups

Treatment group A

Experimental group

Treatment:

Drug: HRS2300

Treatment group B

Experimental group

Treatment:

Drug: HRS2300、 SHR-1316

Treatment group C

Experimental group

Treatment:

Drug: HRS2300、SHR-1701

Treatment group D

Experimental group

Treatment:

Drug: HRS2300、trametinib

Treatment group E

Experimental group

Treatment:

Drug: HRS2300、Almonertinib