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CA-4948

Phase 1

Gastric Cancer | Small molecule | Oncology |Curis, Inc.|Last Updated: Apr 27, 2026

Target and mechanism

Molecular targetIRAK4
Target classKinase
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

CA-4948 · 1 trial · 5 indications

Phase 1 1
NCT05187182CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal CancerGastric Cancer
RECRUITING42 Analytics
PHASE1RECRUITING
CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of regimen as measured by number of adverse events
From start of treatment through 30 days after completion of treatment (estimated to be 15 months)
Expansion dose of CA-4948 in combination with FOLFOX/PD-1 inhibitor with/without trastuzumab
Completion of 2 cycles (each cycle is 14 days) for all participants enrolled in Dose Escalation portion of the study (estimated to be 19 months)

Secondary Endpoints

Progression-free rate (PFR)
At 6 months
Disease control rate (DCR)
At 6 months post study completion (estimated to be 20 months)
Overall response rate (ORR) per RECIST 1.1
Through completion of treatment (estimated to be 14 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation (CA4948 + FOLFOX + Nivolumab)EXPERIMENTAL* CA4948 (dose will depend on dose level assigned) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days.
Dose Expansion Cohort A (CA4948 + FOLFOX + Nivolumab)EXPERIMENTAL* CA4948 (dose will be the recommended phase II dose found in the dose escalation portion of study) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days.
Dose Expansion Cohort B (CA4948 + FOLFOX + Pembrolizumab + Trastuzumab)EXPERIMENTAL* CA4948 (dose will be the recommended dose found in the dose escalation portion of study) twice daily by mouth Standard of care mFOLFOX7 every 14 days. Pembrolizumab on day 1 of every 3 cycles. Trastuzumab every 14 days. * Each cycle is 14 days.

Interventions

NameTypeDescription
CA-4948DRUGProvided by Curis, Inc.
NivolumabBIOLOGICAL240 mg IV on Day 1 of each cycle
PembrolizumabBIOLOGICAL400 mg IV on Day 1 of every 3 cycles (C1D1, C4D1, C7D1,…) and dosing may continue for a max of 2 years
TrastuzumabDRUG6 mg/kg IV loading dose on Cycle 1 Day 1 and 4 mg/kg IV on Day 1 of every subsequent cycle
mFOLFOX7DRUGStandard of care
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the stomach, gastroesophageal junction, or esophagus * Measurable or evaluable disease defined by RECIST 1.1. * Lesions amenable to research biopsy. This ...

Countries:United States
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Competitive Landscape -Gastric Cancer 112 trials

Top 20 of 45 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab, paclitaxel, Paclitaxel, Docetaxel
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY6PHASE2Pumitamig, Folfox, Capox, Nivolumab
Pfizer Inc.PFE7PHASE2disitamab vedotin, tucatinib
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography/Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106- Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed/m2, Cisplatin/m2
Incyte CorporationINCY1PHASE2Capecitabine, Oxaliplatin, Retifanlimab
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
Enliven Therapeutics, Inc.ELVN1PHASE1ELVN-002, Trastuzumab, 5-Fluorouracil, Oxaliplatin, Capecitabine
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Frequently asked questions about CA-4948

What is CA-4948 used for in gastric cancer?

CA-4948 is an investigational small molecule being studied for the treatment of gastric cancer, specifically in combination with FOLFOX and a PD-1 inhibitor, with or without trastuzumab, for untreated unresectable gastric and esophageal cancer. It is currently in Phase 1 clinical development.

What does CA-4948 target?

CA-4948 targets IRAK4, a kinase enzyme involved in inflammatory signaling pathways. By inhibiting IRAK4, CA-4948 may interfere with tumor-promoting signals in cancer cells. This mechanism is being explored in the context of gastric and esophageal cancers.

Who makes CA-4948?

CA-4948 is being developed by Curis, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRIS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in oncology.

What phase is CA-4948 in?

CA-4948 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in combination therapies for gastric and esophageal cancers.

What clinical trials is CA-4948 in?

CA-4948 is being studied in a Phase 1 clinical trial with the identifier NCT05187182. This trial is evaluating CA-4948 in combination with FOLFOX and a PD-1 inhibitor, with or without trastuzumab, in patients with untreated unresectable gastric and esophageal cancer. The trial is recruiting in the United States and aims to enroll 42 participants.

Is CA-4948 the same as emavusertib?

No, CA-4948 is not the same as emavusertib. CA-4948 is a distinct investigational small molecule targeting IRAK4, developed by Curis, Inc. It is being studied for gastric and esophageal cancers. Emavusertib is a different drug with its own development program and target.