← Back to Search

Small Molecule Drug

D-1553 for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by InventisBio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.

Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.

Must not have

Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;

Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, typical side effects of new cancer drugs like D-1553 may include nausea, fatigue, diarrhea, liver enzyme changes leading to potential liver damage; blood count abnormalities which could result in increased infection risk or bleeding; rash; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had a recent heart attack or severe heart problems.

Select...

I haven't had major surgery in the last 4 weeks or radiation therapy in the last 2 weeks.

Select...

I do not have an ongoing lung infection or disease, including COVID-19.

Select...

I still have side effects from cancer treatment, except for hair loss, that are not mild.

Select...

My cancer has spread to my brain and is getting worse.

Select...

I have a digestive condition that affects how my body absorbs pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2 of D-1553 monotherapy and combination therapiesExperimental Treatment2 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 monotherapyExperimental Treatment1 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 therapiesExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

D-1553

2021

Completed Phase 2

~270

0 / 9Eligibility criteria met