BPI-572270 in RAS-mutant advanced solid tumors (including NSCLC, CRC, PDAC)

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 is a Phase 1/2, multicenter, open-label trial to assess safety, tolerability, PK, and preliminary efficacy of escalating doses of BPI-572270 in adults with RAS-mutant advanced solid tumors. The study aims to identify the maximum tolerated dose or the recommended phase 2 dose and to expand to evaluate efficacy endpoints such as objective response rate, disease control rate, duration of response, and time to response. Eligible cancers include NSCLC, colorectal cancer, pancreatic ductal adenocarcinoma, and other advanced solid tumors with confirmed RAS mutations after prior therapy. Key eligibility requires adequate organ function and good performance status; major exclusions include active CNS metastases and significant GI absorption issues.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.
* Have received prior standard therapy appropriate for tumor type and stage.
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function.

Exclusion Criteria:

* Primary central nervous system (CNS) tumors active and untreated brain metastases.
* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication.
* History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting
• Blacktown Hospital
  Blacktown, New South Wales, Australia Not yet recruiting
• Scientia Clinical Research
  Randwick, New South Wales, Australia Not yet recruiting
• GenesisCare St Leonards, 7 Westbourne St, St Leonards
  Sydney, New South Wales, Australia Not yet recruiting
• Southern Oncology Clinical Research Unit (SOCRU)
  Bedford Park, South Australia, Australia Not yet recruiting
• Warringal Private Hospital
  Heidelberg, Victoria, Australia Not yet recruiting

Similar studies

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

• RMC-5127 for advanced cancers with KRAS G12V mutation

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• Evaluating RMC-9805 for KRAS G12D-Mutant Solid Tumors

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• Evaluating RMC-6236 for advanced solid tumors with specific RAS mutations

  This study is testing a new drug called RMC-6236 to see if it can help adults with advanced solid tumors that have certain RAS mutations.

  Recruiting at 21 sites Phase 1/2 Revolution Medicines, Inc. · Orange, California and 20 other locations · NCT05379985

• Combining RAS(ON) inhibitors with ivonescimab for adults with RAS‑mutant advanced solid tumors

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• BMS-986523 alone and with other cancer medicines for advanced KRAS-altered solid tumors

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  Recruiting at 6 sites Phase 1/2 Bristol-Myers Squibb · Baltimore, Maryland and 7 other locations · NCT07223047

• JYP0015 for adults with advanced RAS‑mutant solid tumors

  This trial tests whether the oral drug JYP0015 is safe and can shrink tumors in adults whose advanced solid cancers have specific RAS mutations.

  Recruiting Phase 2 Guangzhou JOYO Pharma Co., Ltd · Beijing, Beijing Municipality · NCT06895031

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.