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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 3 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective in treating people with solid tumors that have a KRasG12C mutation.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects participants with adverse events
Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation.
Subject incidence of Dose-limiting toxicities (DLT)
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.
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Who is running the clinical trial?
InventisBio Inc.Lead Sponsor
7 Previous Clinical Trials
719 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,794 Total Patients Enrolled
InventisBio Co., LtdLead Sponsor
19 Previous Clinical Trials
1,779 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are medical facilities in this region engaged with the trial?
"Currently, 8 distinct medical centres are running this experiment. Cities such as Louisville, Pittsburgh, and San Francisco all host one of these sites; to lessen the burden on participants, it is beneficial to opt for a clinical trial located closest to you."
Answered by AI
How many participants are involved with this clinical experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this clinical trial is currently enrolling patients and has been since October 2nd 2020; with the data being most recently updated March 28th 2022. This study requires 200 participants sourced from 8 different medical sites."
Answered by AI
Are there any current opportunities to enroll in this clinical experiment?
"Clinicaltrials.gov confirms that this clinical trial, which was initially posted in October 2020, is still actively seeking participants. The trial details have been updated as recently as March 2022."
Answered by AI
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