D-1553 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called D-1553, a potential drug for individuals with advanced or spreading solid tumors, specifically those with a KRasG12C mutation. The trial aims to determine the safety and effectiveness of D-1553, both alone and in combination with other treatments. Suitable participants have tumors that standard methods cannot treat and possess the KRasG12C mutation, including cancers such as non-small cell lung cancer and colorectal cancer. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that D-1553 is generally safe for patients with solid tumors that have the KRAS G12C mutation. Patients taking D-1553 alone have mostly tolerated the treatment well, even after receiving many other treatments. Additionally, combining D-1553 with another drug, ifebemtinib, has proven manageable in terms of side effects, keeping them under control. While more research is needed, these initial findings suggest that D-1553 is relatively safe for use in humans.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about D-1553 because it specifically targets the KRasG12C mutation, a genetic change found in several solid tumors, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Unlike other treatments that may not be mutation-specific, D-1553 aims to directly inhibit the mutant protein, potentially offering a more precise and effective approach. Additionally, the combination of D-1553 with other therapies could enhance treatment outcomes by attacking the cancer through multiple pathways. This targeted strategy could lead to better responses and fewer side effects compared to broader treatments like chemotherapy.
What evidence suggests that this trial's treatments could be effective for solid tumors with KRasG12C mutation?
Research has shown that D-1553 holds promise for individuals with solid tumors carrying the KRasG12C mutation. Earlier studies found D-1553 to be safe for patients and effective in shrinking tumors. Even for those who had undergone multiple treatments, D-1553 demonstrated efficacy, suggesting it might help when other treatments have not. In this trial, participants will receive D-1553 either as a monotherapy or in combination with other therapies. When combined with therapies like ifebemtinib, D-1553 also produced positive results, indicating its potential effectiveness as part of a combined approach against cancer. This makes D-1553 a hopeful option for those with hard-to-treat tumors.12346
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
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.
Dose Combination
Phase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors.
Phase 2
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- D-1553
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
InventisBio Inc.
Lead Sponsor
InventisBio Co., Ltd
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
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
Citations
Safety and efficacy of D-1553 in KRAS G12C-mutated ...
Conclusions: D-1553 demonstrated a tolerable safety profile and promising monotherapy activity in pts with heavily pretreated locally advanced ...
Study to Evaluate D-1553 in Subjects With Solid Tumors
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
622P Safety and efficacy of ifebemtinib (IN10018) ...
The combination of ifebemtinib and D-1553, as a dual-oral regimen, showed promising antitumor activity and manageable safety profile in KRAS G12C mutant solid ...
Safety and efficacy of D-1553 in KRAS G12C-mutated ...
Background: KRAS G12C mutation is an oncogenic driver that occurs in 3-4% of colorectal cancer (CRC). D-1553 is a novel oral and potent KRASG12C inhibitor.
D‐1553: A novel KRASG12C inhibitor with potent and ...
Here, we report the preclinical data demonstrating antitumor activity of D‐1553. Potency and specificity of D‐1553 in inhibiting GDP‐bound KRAS ...
Safety and efficacy of ifebemtinib (IN10018) combined with ...
This study is to evaluate the safety and antitumor activity of ifebemtinib combined with D-1553 in solid tumors with KRAS G12C mutation.
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