Clinical trial · Interventional

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

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

NCT06435455CI-TRIAL-00078591not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
D-1553	Drug	—	UNRESOLVED
GH21	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
"GH21 + D-1553" Group
description
GH21 capsules combined with D-1553 tablets were administrated orally
interventionNames
1. Drug: GH21
2. Drug: D-1553

Primary outcomes (2)

measure
Dose-limiting Toxicities Incidence Count Among Study
timeFrame
2 years
description
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.
measure
Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective
timeFrame
2 years
description
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.