Treatment for advanced solid tumors with a specific KRAS mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of D3S-001, either alone or in combination with other therapies, for patients with advanced solid tumors that have a KRAS p.G12C mutation. It is a first-in-human, multicenter, open-label trial that includes both dose-escalation and dose-expansion phases. Participants will take D3S-001 orally in 21-day treatment cycles, and the study will assess pharmacokinetics, pharmacodynamics, and preliminary efficacy of the treatment.

Why it matters

Who can join: the full rules

Inclusion:

* Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
* Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
* Subject must have measurable disease per RECIST v1.1.
* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject must have adequate organ and marrow function within the screening period.

Exclusion:

* Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
* Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
* Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).

Other protocol inclusion/exclusion criteria may apply

Where it's running

• D3 Bio Investigative Site 0402
  Orange, California, United States Recruiting
• D3 Bio Investigative Site 0407
  Palo Alto, California, United States Recruiting
• D3 Bio Investigative Site 0404
  Denver, Colorado, United States Recruiting
• D3 Bio Investigative Site 0406
  Sarasota, Florida, United States Recruiting
• D3 Bio Investigative Site 0401
  Detroit, Michigan, United States Recruiting
• D3 Bio Investigative Site 0405
  Nashville, Tennessee, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medical Director
• Email: D3bio_CT@d3bio.com
• Phone: +86 21 61635900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating JAB-21822 for pancreatic cancer and other solid tumors with a specific mutation

  This study is testing a new drug called Glecirasib to see if it can help adults with advanced pancreatic cancer or other solid tumors that have a specific mutation and who haven't had success with other treatments.

  Recruiting at 29 sites Phase 2 Allist Pharmaceuticals, Inc. · Hefei, Anhui and 30 other locations · NCT06008288

• Treatment of advanced lung cancer with sotorasib for patients with a specific KRAS mutation

  This study is testing if a new drug called sotorasib can help people with advanced lung cancer who have a specific KRAS mutation and have already tried other treatments.

  Recruiting at 4 sites Phase 2 Gustave Roussy, Cancer Campus, Grand Paris · Lyon and 4 other locations · NCT05631249

• Treatment of advanced lung cancer with Sotorasib for patients unable to undergo chemotherapy.

  This study is testing if a new drug called Sotorasib can help people with advanced lung cancer who can’t have chemotherapy live longer without their disease getting worse.

  Recruiting at 20 sites Phase 2 Fundación GECP · Alicante, Alicante and 19 other locations · NCT05398094

• Testing JAB-21822 and JAB-3312 in patients with advanced solid tumors and KRAS p.G12C mutation

  This study is testing a new combination of drugs, JAB-21822 and JAB-3312, to see if it helps people with advanced solid tumors that have a specific KRAS mutation.

  Recruiting at 3 sites Phase 1/2 Allist Pharmaceuticals, Inc. · Hefei, Anhui and 26 other locations · NCT05288205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.