Solid TumorsPhase 1/2NCT07819136
REC-7735 in Participants With Solid Tumors
A Phase 1/2 study testing REC-7735 in people with Solid Tumors, run by Recursion Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- REC-7735
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Jan 2031
- 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
- Participants have histologically-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid [ctDNA]).
- For Phase 1A and planned monotherapy cohorts in Phase 1B, participants have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or in the opinion of the Investigator have been considered ineligible for standard therapy.
- All toxicities from prior anti-cancer therapies have resolved to ≤ Grade 1 or the participant's previous baseline, with the exception of alopecia and peripheral neuropathy.
Who cannot join
- Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka), protein kinase B (AKT) or mechanistic target of rapamycin (mTOR) inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.
- Known loss-of-function mutations in phosphatase and tensin homolog (PTEN), PTEN loss, or activating mutations in AKT, unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.
- Major surgery within 6 weeks from treatment initiation.
- Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the participant to receive or tolerate the planned treatment.
- Recent or ongoing serious infection.
- Recent prior systemic anti-cancer treatment.
Show all 14Show fewer
- Known clinically significant UGT1A1 deficiency, including Gilbert's syndrome (for example, documented homozygous UGT1A1*28)
- Has an established diagnosis of uncontrolled diabetes mellitus defined as meeting any one of the following:
- NOTE: This criterion is not applicable to those participants enrolling in the Phase 1B Dose Expansion cohort designated for hyperglycemia vulnerable participants
- Glycated hemoglobin (HbA1c) ≥8%
- Currently requiring insulin
- Fasting blood glucose (FBG) ≥140 milligrams (mg)/deciliter (dL) (7.8 millimoles [mmol]/liter [L]) in the past 30 days prior to dosing
- NOTE: Two FBG samples must be drawn at least seven days apart from each other.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Referral Coordinator, 703-783-4518, mdelarosa@nextoncology.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Hope Team Distribution List, hopeteam@startresearch.com
- Recruiting
NEXT Oncology - Dallas
Irving, Texas, 75039
Clinical Trial Navigator, 972-893-8800, fakinwale@nextoncology.com
About this study
Official title: A Phase 1 / 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors
The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.
- Conditions
- Solid Tumors
- Being tested
- REC-7735
- Keywords
- PIK3CA-H1047R, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REC-7735Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Phase 1A Dose Finding: REC-7735 | Experimental | Participants will receive REC-7735 twice daily (BID). Receives: Drug: REC-7735 |
| Phase 1B Dose Expansion/Optimization: REC-7735 | Experimental | Participants will receive REC-7735 BID. Receives: Drug: REC-7735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)
Measured: 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 2 years
Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to 2 years
Secondary outcomes (10)
Maximum (Peak) Drug Concentration (Cmax) of REC-7735
Measured: Up to 2 years
Time to Reach Cmax following drug administration (Tmax) of REC-7735
Measured: Up to 2 years
Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735
Measured: Up to 2 years
Phase 1A: ORR According to Standard RECIST 1.1
Measured: Up to 2 years
Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1
Measured: Up to 2 years
Phase 1B: Duration of Response (DOR) According to Standard RECIST 1.1
Measured: Up to 2 years
Phase 1B: Duration of Stable Disease (SD) According to Standard RECIST 1.1
Measured: Up to 2 years
Phase 1B: Time to Response (TTR) According to Standard RECIST 1.1
Measured: Up to 2 years
Phase 1B: Progression-free Survival (PFS) According to Standard RECIST 1.1
Measured: Up to 2 years
Phase 1B: Overall Survival
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recursion Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819136
- Sponsor's protocol ID
- REC-7735-101
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 / 2, Open-Label Study of REC-7735 in Participants With Unresectable, Locally Advanced, or Metastatic PIK3CA-H1047R Mutated Solid Tumors
- ClinicalTrials.gov ID
- NCT07819136
- Acronym / sponsor ID
- REC-7735-101
- Conditions
- Solid Tumors
- Keywords
- PIK3CA-H1047R, Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Recursion Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 14 Sep 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.
The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1A Dose Finding: REC-7735 | Experimental | Drug: REC-7735Participants will receive REC-7735 twice daily (BID). |
| Phase 1B Dose Expansion/Optimization: REC-7735 | Experimental | Drug: REC-7735Participants will receive REC-7735 BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants have histologically-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid [ctDNA]).
- For Phase 1A and planned monotherapy cohorts in Phase 1B, participants have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or in the opinion of the Investigator have been considered ineligible for standard therapy.
- All toxicities from prior anti-cancer therapies have resolved to ≤ Grade 1 or the participant's previous baseline, with the exception of alopecia and peripheral neuropathy.
Key exclusion criteria (14 listed)
- Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka), protein kinase B (AKT) or mechanistic target of rapamycin (mTOR) inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.
- Known loss-of-function mutations in phosphatase and tensin homolog (PTEN), PTEN loss, or activating mutations in AKT, unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.
- Major surgery within 6 weeks from treatment initiation.
- Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the participant to receive or tolerate the planned treatment.
- Recent or ongoing serious infection.
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 |
|---|---|---|
| REC-7735Oral | Drug | Phase 1A Dose Finding: REC-7735, Phase 1B Dose Expansion/Optimization: REC-7735 |
Primary outcome
Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 years
Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 2 years
10 secondary outcomes
Maximum (Peak) Drug Concentration (Cmax) of REC-7735
Time frame: Up to 2 years
Time to Reach Cmax following drug administration (Tmax) of REC-7735
Time frame: Up to 2 years
Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735
Time frame: Up to 2 years
Phase 1A: ORR According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Clinical Benefit Rate (CBR) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Duration of Response (DOR) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Duration of Stable Disease (SD) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Time to Response (TTR) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Progression-free Survival (PFS) According to Standard RECIST 1.1
Time frame: Up to 2 years
Phase 1B: Overall Survival
Time frame: Up to 2 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 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 2
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
Solid Tumors, Lymphoma
RecruitingPhase 1
Study of Lunresertib Alone or in Combination With RP-3500 or Zedoresertib (Debio 0123) in Patients With Advanced Solid Tumors
Advanced Solid Tumor
Active, not recruitingPhase 1
A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation
Solid Tumors, KRAS Mutation
RecruitingPhase 1/2
Study of SGN1 in Patients With Advanced Solid Tumor
Advanced Solid Tumor
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REC-7735 in people with Solid Tumors, run by Recursion Pharmaceuticals Inc. at 3 sites in United States.
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 14 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 29 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 3 sites in United States. 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?
Contact Recursion Pharmaceuticals (385-374-1724, clinicaltrials@recursionpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: 28 days). 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 29 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.