UnresectablePhase 1/2DAHLIANCT06678659
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
A Phase 1/2 study testing REC-1245 in people with Unresectable and Locally Advanced, run by Recursion Pharmaceuticals Inc. at 7 sites in 2 countries.
Trial summary
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Unresectable, Locally Advanced, Metastatic Cancers
- What is being tested?
- REC-1245
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 21 Nov 2024to 30 Oct 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma
- 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 have been considered ineligible for standard therapy.
- Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70.
- Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)
Who cannot join
- Received treatment with another RBM39 degrader
- Clinically significant gastrointestinal (GI) or GI malabsorption
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
United States5 sites, 4 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Jessica Grenbenc, 216-444-7923, canceranswer@ccf.org
- Recruiting
City of Hope
Duarte, California, 91010
Mihae Song, 877-467-3411, misong@coh.org
- Withdrawn
SCRI Oncology Partners - PPDS
Nashville, Tennessee, 37203
- Recruiting
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Victoria Chua, 310-552-9999, chua@sarcomaonology.com
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Marie Asay, 801-907-4750, marie.asay@startresearch.com
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Centre (MUHC) - The Montreal
Québec, H4A3J1
Phuong-nam Nguyen, 5149341934, Phuong-nam.Nguyen@muhc.mcgill.ca
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1X6
Anh Nguyen, 416-946-4501, anh.nguyen2@uhn.ca
About this study
Official title: A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
Read the detailed description
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.
- Being tested
- REC-1245
- Keywords
- RBM39, Cancer, Refractory Lymphomas, Metastatic Cancers
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REC-1245Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a | Experimental | Dose Finding Receives: Drug: REC-1245 |
| Phase 1b Cohort A | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 1b Cohort B | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 1b Cohort C | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 1b Cohort D | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 2 Cohort 1 Dose #1 | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 2 Cohort 1 Dose #2 | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 2 Cohort 2 Dose #1 | Experimental | Not described Receives: Drug: REC-1245 |
| Phase 2 Cohort 2 Dose #2 | Experimental | Not described Receives: Drug: REC-1245 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)
To characterize the incidence of DLTs
Measured: Initiation of study drug through 4 weeks
Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event
To characterize the incidence of treatment emergent adverse events
Measured: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)
Phase 2- Objective Response Rate (ORR)
To assess tumor response
Measured: Initiation from study drug until disease progression (up to approximately 24 months)
Secondary outcomes (11)
Phase 1- ORR
To assess tumor response
Measured: Initiation from study drug until disease progression (up to approximately 24 months)
Phase 1 and 2- Disease Control Rate (DCR)
To assess the anti-tumor activity
Measured: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Duration of Response (DOR)
To assess the anti-tumor activity
Measured: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Duration of Stable Disease (SD)
To assess the anti-tumor activity
Measured: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Time to Response (TTR)
To assess the anti-tumor activity
Measured: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Progression Free Survival (PFS)
To assess the anti-tumor activity
Measured: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Overall Survival (OS)
To assess the anti-tumor activity
Measured: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 - Maximum Plasma Concentration (Cmax)
To characterize PK of REC-1245
Measured: Initiation of study drug through Week 9
Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax)
To characterize PK of REC-1245
Measured: Initiation of study drug through Week 9
Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)
To characterize PK of REC-1245
Measured: Initiation of study drug through Week 9
Phase 1 - Area Under Plasma Concentration-time Curve (AUC)
To characterize PK of REC-1245
Measured: Initiation of study drug through Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start21 Nov 2024
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UnresectableStudies 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
- Model description
- "Phase 1a: Dose Finding; Phase 1b: Dose Expansion; Phase 2: Randomized"
- Masking
- None (open label)
- Enrolment
- 170 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
- NCT06678659
- Sponsor's protocol ID
- REC-1245-101
- Acronym
- DAHLIA
- Status last verified
- Aug 2026
- First submitted
- 29 Oct 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Aug 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-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT06678659
- Acronym / sponsor ID
- DAHLIA / REC-1245-101
- Keywords
- RBM39, Cancer, Refractory Lymphomas, Metastatic Cancers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Recursion Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 7 Nov 2024 (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.
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
Detailed description
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- "Phase 1a: Dose Finding; Phase 1b: Dose Expansion; Phase 2: Randomized"
| Arm | Type | Receives |
|---|---|---|
| Phase 1a | Experimental | Drug: REC-1245Dose Finding |
| Phase 1b Cohort A | Experimental | Drug: REC-1245 |
| Phase 1b Cohort B | Experimental | Drug: REC-1245 |
| Phase 1b Cohort C | Experimental | Drug: REC-1245 |
| Phase 1b Cohort D | Experimental | Drug: REC-1245 |
| Phase 2 Cohort 1 Dose #1 | Experimental | Drug: REC-1245 |
| Phase 2 Cohort 1 Dose #2 | Experimental | Drug: REC-1245 |
| Phase 2 Cohort 2 Dose #1 | Experimental | Drug: REC-1245 |
| Phase 2 Cohort 2 Dose #2 | Experimental | Drug: REC-1245 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma
- 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 have been considered ineligible for standard therapy.
- Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70.
- Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)
Key exclusion criteria (2 listed)
- Received treatment with another RBM39 degrader
- Clinically significant gastrointestinal (GI) or GI malabsorption
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-1245Oral | Drug | Phase 1a, Phase 1b Cohort A, Phase 1b Cohort B, Phase 1b Cohort C, Phase 1b Cohort D, Phase 2 Cohort 1 Dose #1, Phase 2 Cohort 1 Dose #2, Phase 2 Cohort 2 Dose #1, Phase 2 Cohort 2 Dose #2 |
Primary outcome
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Initiation of study drug through 4 weeks
To characterize the incidence of DLTs
Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event
Time frame: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)
To characterize the incidence of treatment emergent adverse events
Phase 2- Objective Response Rate (ORR)
Time frame: Initiation from study drug until disease progression (up to approximately 24 months)
To assess tumor response
11 secondary outcomes
Phase 1- ORR
Time frame: Initiation from study drug until disease progression (up to approximately 24 months)
Phase 1 and 2- Disease Control Rate (DCR)
Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Duration of Response (DOR)
Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Duration of Stable Disease (SD)
Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Time to Response (TTR)
Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Progression Free Survival (PFS)
Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Overall Survival (OS)
Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 - Maximum Plasma Concentration (Cmax)
Time frame: Initiation of study drug through Week 9
Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Initiation of study drug through Week 9
Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)
Time frame: Initiation of study drug through Week 9
Phase 1 - Area Under Plasma Concentration-time Curve (AUC)
Time frame: Initiation of study drug through Week 9
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
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 REC-1245 in people with Unresectable and Locally Advanced, run by Recursion Pharmaceuticals Inc. 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 4 inclusion and 2 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 20 Aug 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 United States, Canada. 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?
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Initiation of study drug through 4 weeks). 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 20 Aug 2026.