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

NCT05048134 | Terminated Phase 1

• 1 other identifier: HRS2300-I-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (3)

• Number of participants with Dose limited toxicity（DLT）

  Cycle 1( 4 weeks- monotherapy；3 weeks -combination）

• Number of participants with adverse events

  up to 3 years; at least once per treatment cycle

• Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy

  Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data.

  through study completion，an average of 2 years

Study Arms (5)

Treatment group A

EXPERIMENTAL

Drug: HRS2300

Treatment group B

EXPERIMENTAL

Drug: HRS2300、 SHR-1316

Treatment group C

EXPERIMENTAL

Drug: HRS2300、SHR-1701

Treatment group D

EXPERIMENTAL

Drug: HRS2300、trametinib

Treatment group E

EXPERIMENTAL

Drug: HRS2300、Almonertinib

Interventions

HRS2300 DRUG

HRS2300 monotherapy

Treatment group A

HRS2300、 SHR-1316 DRUG

HRS2300 combined with SHR-1316

Treatment group B

HRS2300、SHR-1701 DRUG

HRS2300 combined with SHR-1701

Treatment group C

HRS2300、trametinib DRUG

HRS2300 combined with trametinib

Treatment group D

HRS2300、Almonertinib DRUG

HRS2300 combined with Almonertinib

Treatment group E

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old，Male or female;
• 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;
• ECOG PS score of 0-1;
• Life expectancy of ≥3 months;
• Able and willing to provide a written informed consent.

You may not qualify if:

• 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;
• 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;
• 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;
• Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS2300 monotherapy or combined with SHR-1316, SHR-1701, trametinib, and Almonertinib

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 17, 2021
• Study Start: October 25, 2021
• Primary Completion: February 24, 2023
• Study Completion: May 23, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)