Non-small Cell Lung Cancer (NSCLC)Phase 1/2NCT07435038
Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
A Phase 1/2 study testing BPI-572270 in people with Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), run by Betta Pharmaceuticals Co., Ltd. at 7 sites in 2 countries.
Trial summary
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- BPI-572270
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 29 Jan 2026to 28 Oct 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Australia6 sites, 6 recruiting
- Not yet recruiting
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, 5042
Meggan O'Riley, 0491 679 039, meggan.oriley@socru.org.au
Ganessan Kichenadasse, Dr
- Not yet recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
Rebecca Hinshelwood, 8670 5071, rebecca.hinshelwood@health.nsw.gov.au
- Not yet recruiting
Warringal Private Hospital
Heidelberg, Victoria, 3084
Zahra Thompson, MD/PhD, 03 9251 6589, ClinicalTrials.WRP@ramsayhealth.com.au
Niall Prof Tebbutt
- Not yet recruiting
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
Rajiv N Shinde, Dr, 08 63825100, Rajiv.Shinde@health.wa.gov.au
Timothy Humphries, Dr, 08 63825100, Timothy.humphries@health.wa.gov.au
- Not yet recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
Charlotte Lemech, Dr, MBBS, 02 9382 5800, contactus@scientiaclinicalresearch.com.au
Charlotte Lemech
- Not yet recruiting
GenesisCare St Leonards, 7 Westbourne St, St Leonards
Sydney, New South Wales, 2065
Mykhailo Saiko, Clinical Research State Lead, 0477637995, Mykhailo.Saiko@genesiscare.com
Nick Pavlakis, Prof
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, 86-0571-88122088, songzb@zjcc.org.cn
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
Read the detailed description
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR/DCR/DOR/TTR).
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Being tested
- BPI-572270
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-572270Drug
Also called BPI-572270 Capsule
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Study BPI-572270 in adults with specific RAS mutant advanced solid tumors | Experimental | Capsules; Administer once a day on an empty stomach. Receives: Drug: BPI-572270 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs
Measured: up to 2 tears
RP2D
Determination of RP2D in the expansion phase
Measured: up to 2 tears
ORR
Further expand the inclusion to clarify the efficacy endpoint ORR
Measured: up to 3 tears
Secondary outcomes (3)
Cmax
Maximum Observed Blood Concentration (Cmax) of BPI-572270
Measured: up to 15 weeks
AUC
Area Under Blood Concentration Time Curve (AUC) of BPI-572270
Measured: up to 15 weeks
Disease Control Rate (DCR)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start29 Jan 2026
- Primary completion28 Dec 2028 (estimated)
- Study completion28 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435038
- Sponsor's protocol ID
- BTP-662011
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No