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Not yet recruiting NCT06435455

GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors

Phase I / Phase II Interventional Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GH21, D-1553.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

Overview

This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.

Detailed description

This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.

Interventions

  • Drug GH21
    GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule
  • Drug D-1553
    D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet

Primary outcome measures

  • Dose-limiting Toxicities Incidence Count Among Study [Time frame: 2 years]
  • Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective [Time frame: 2 years]
Secondary outcome measures (8)
  • response rate (ORR) based on RECIST 1.1 criteria [Time frame: 2 years]
  • Duration of response (DOR) based on RECIST 1.1 criteria [Time frame: 2 years]
  • Disease Control Rate (DCR) based on RECIST 1.1 criteria [Time frame: 2 years]
  • Progression-free survival (PFS) based on RECIST 1.1 criteria [Time frame: 2 years]
  • Overall survival (OS) [Time frame: 2 years]
  • Plasma concentration (Cmax) [Time frame: 2 years]
  • Time to achieve Cmax (Tmax) [Time frame: 2 years]
  • Area under the plasma concentration-time curve (AUC) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
  • Age ≥18 years old, male or female;
  • KRAS G12C mutant advanced solid tumor;
  • ECOG Performance Status of 0 or 1
  • At least one measurable lesion as defined by RECIST 1.1

Exclusion criteria

  • acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;
  • Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
  • There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
  • Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
  • Pregnant and lactating women;
  • The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06435455 · GH21C203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗