D-1553 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: InventisBio Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called D-1553 on patients with advanced or metastatic solid tumors that have the KRasG12C mutation. The drug works by blocking a faulty gene in cancer cells to stop tumor growth. Sotorasib and Adagrasib are earlier drugs targeting the KRAS G12C mutation, with Sotorasib being the first to receive FDA approval.

Research Team

Eligibility Criteria

This trial is for adults with advanced solid tumors, including lung and colorectal cancer, that have no standard treatment options or haven't responded to existing treatments. Participants must have a specific mutation (KRasG12C) in their tumor and measurable disease according to certain criteria. They can't join if they have unstable brain metastases, recent heart issues or stroke, unresolved toxicities from past cancer therapy, impaired GI function affecting drug absorption, major surgery within the last month, or are pregnant.

Inclusion Criteria

My cancer is advanced or has spread to other parts of my body.

My cancer has the KRasG12C mutation.

My advanced cancer has no standard treatment options left, or I can't tolerate them.

Exclusion Criteria

I have not had a stroke or severe brain blood flow problems in the last year.

Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).

Subject has any history or evidence of substance abuse or medical, psychological or social conditions that may, in the opinion of the investigator, interfere with participation in the study or evaluation of the study results.

Treatment Details

Interventions

• D-1553 (Small Molecule Drug)

Trial Overview The study is testing D-1553 alone and combined with other treatments in patients with solid tumors carrying the KRasG12C mutation. It aims to determine safe dosage levels (MTD), recommended phase 2 dosages (RP2D), how the body processes the drug (PK properties), and its effectiveness against tumors.

Participant Groups

Group I: Phase 2 of D-1553 monotherapy and combination therapies Experimental Treatment 2 Interventions

The Phase 2 portion is a multi-arm, parallel, open label study to evaluate the efficacy of D- 1553 single agent and combination treatments in subjects with advanced or metastatic solid tumors with KRas G12C mutation. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose.

Group II: Dose escalation of D-1553 monotherapy Experimental Treatment 1 Intervention

Phase 1a will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.

Group III: Dose combination of D-1553 with other therapies Experimental Treatment 2 Interventions

Phase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors. There are multiple groups in Phase 1b for different tumor types and treatment combinations to evaluate safety, MTD and RP2D.

Who Is Running the Clinical Trial?

InventisBio Inc.

Lead Sponsor

Trials

8

Recruited

900+

InventisBio Co., Ltd

Lead Sponsor

Trials

20

Recruited

1,800+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University