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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07435038
- Acronym / sponsor ID
- BTP-662011
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 28 Oct 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study BPI-572270 in adults with specific RAS mutant advanced solid tumors | Experimental | Drug: BPI-572270Capsules; Administer once a day on an empty stomach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPI-572270Also: BPI-572270 CapsuleOral Tablets | Drug | Study BPI-572270 in adults with specific RAS mutant advanced solid tumors |
Primary outcome
DLT
Time frame: up to 2 tears
Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs
RP2D
Time frame: up to 2 tears
Determination of RP2D in the expansion phase
ORR
Time frame: up to 3 tears
Further expand the inclusion to clarify the efficacy endpoint ORR
3 secondary outcomes
Cmax
Time frame: up to 15 weeks
AUC
Time frame: up to 15 weeks
Disease Control Rate (DCR)
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GenesisCare St Leonards, 7 Westbourne St, St Leonards
Sydney, Australia
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: up to 2 tears). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.