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OncoMatch/Clinical Trials/NCT04787042

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

Is NCT04787042 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including ST-067 and Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] for cancer.

Phase 1/2RecruitingSimcha IL-18, Inc.NCT04787042Data as of May 2026

Treatment: ST-067 · Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] · pembrolizumabThis is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Melanoma

Renal Cell Carcinoma

Triple-Negative Breast Cancer

Breast Carcinoma

Small Cell Lung Cancer

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: ESR1 wild-type

TNBC is diagnosed in a tumor which does not express estrogen receptor

Required: PR (PGR) wild-type

TNBC is diagnosed in a tumor which does not express ... progesterone receptor

Required: HER2 (ERBB2) wild-type

TNBC is diagnosed in a tumor which ... is not human epidermal growth factor receptor 2 (HER2) 3+ on IHC or is negative by fluorescence in situ hybridization (FISH)

Required: MSH2 wild-type

MSI high tumor should ... be negative for MSH1/2/6 or PMS-2 by IHC

Required: MSH6 wild-type

MSI high tumor should ... be negative for MSH1/2/6 or PMS-2 by IHC

Required: PMS2 wild-type

MSI high tumor should ... be negative for MSH1/2/6 or PMS-2 by IHC

Required: MSH1 wild-type

MSI high tumor should ... be negative for MSH1/2/6 or PMS-2 by IHC

Required: EGFR wild-type

NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions)

Required: NTRK1 wild-type

NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions)

Required: NTRK2 wild-type

NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions)

Required: NTRK3 wild-type

NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions)

Required: ALK wild-type

NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions)

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: high dose chemotherapy requiring stem cell rescue

Prior high dose chemotherapy requiring stem cell rescue

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy (pembrolizumab)

Exception: only if discontinued due to Grade 3 or higher irAE

Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • HonorHealth Research Institute · Scottsdale, Arizona
  • Sarah Cannon Research Institute at HealthONE · Denver, Colorado
  • Yale Cancer Center · New Haven, Connecticut
  • Moffitt Cancer Center · Tampa, Florida
  • Massachusetts General Hospital · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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