ClinicalTrials.gg
RecruitingNCT06678659DAHLIAUpdated Aug 20, 2026

A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

A Phase 1/2 interventional study of REC-1245 in Unresectable, Locally Advanced and Metastatic Cancers, sponsored by Recursion Pharmaceuticals Inc.. Recruiting at 7 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Primary conditionLymphomaRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma
Why
  1. The study's listed conditions name Lymphoma, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Recursion Pharmaceuticals Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Unresectable
  • Locally Advanced
  • Metastatic Cancers
  • Relapsed/Refractory Lymphomas

Browse trials for

Keywords

  • RBM39
  • Cancer
  • Refractory Lymphomas
  • Metastatic Cancers
03

In context

Lymphoma Reclassified

3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.

This study's planned enrollment of 170 is above the median of 43 across 2,319 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Recursion Pharmaceuticals Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Compared within Lymphoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have -confirmed unresectable, locally advanced, or select solid tumors or select 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.
  • (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Performance Status Scale score of ≥70.
  • at baseline per (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)

Exclusion criteria

Exclusion Criteria:

  • Received treatment with another RBM39 degrader
  • gastrointestinal (GI) or GI malabsorption
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Phase 1a

    Dose Finding

    Drug: REC-1245

  • Experimental
    Phase 1b Cohort A

    Drug: REC-1245

  • Experimental
    Phase 1b Cohort B

    Drug: REC-1245

  • Experimental
    Phase 1b Cohort C

    Drug: REC-1245

  • Experimental
    Phase 1b Cohort D

    Drug: REC-1245

  • Experimental
    Phase 2 Cohort 1 Dose #1

    Drug: REC-1245

  • Experimental
    Phase 2 Cohort 1 Dose #2

    Drug: REC-1245

  • Experimental
    Phase 2 Cohort 2 Dose #1

    Drug: REC-1245

  • Experimental
    Phase 2 Cohort 2 Dose #2

    Drug: REC-1245

Interventions

  • DrugREC-1245

    Oral

06

What researchers measure

Primary outcomes

  1. Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)

    To characterize the incidence of DLTs

    Time frame: Initiation of study drug through 4 weeks

  2. Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event

    To characterize the incidence of treatment emergent adverse events

    Time frame: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)

  3. Phase 2- Objective Response Rate (ORR)

    To assess tumor response

    Time frame: Initiation from study drug until disease progression (up to approximately 24 months)

Secondary outcomes

  1. Phase 1- ORR

    To assess tumor response

    Time frame: Initiation from study drug until disease progression (up to approximately 24 months)

  2. Phase 1 and 2- Disease Control Rate (DCR)

    To assess the anti-tumor activity

    Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)

  3. Phase 1 and 2 - Duration of Response (DOR)

    To assess the anti-tumor activity

    Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)

  4. Phase 1 and 2 - Duration of Stable Disease (SD)

    To assess the anti-tumor activity

    Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)

  5. Phase 1 and 2 - Time to Response (TTR)

    To assess the anti-tumor activity

    Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)

  6. Phase 1 and 2 - Progression Free Survival (PFS)

    To assess the anti-tumor activity

    Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)

  7. Phase 1 and 2 - Overall Survival (OS)

    To assess the anti-tumor activity

    Time frame: Initiation from study drug until disease progression as applicable (up to approximately 24 months)

  8. Phase 1 - Maximum Plasma Concentration (Cmax)

    To characterize PK of REC-1245

    Time frame: Initiation of study drug through Week 9

  9. Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax)

    To characterize PK of REC-1245

    Time frame: Initiation of study drug through Week 9

  10. Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)

    To characterize PK of REC-1245

    Time frame: Initiation of study drug through Week 9

  11. Phase 1 - Area Under Plasma Concentration-time Curve (AUC)

    To characterize PK of REC-1245

    Time frame: Initiation of study drug through Week 9

07

Study locations

6 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06678659
Lead sponsor
Recursion Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Nov 7, 2024
Start date
Nov 21, 2024
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Aug 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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