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ADVANCED SOLID TUMORS: LATE LINE: GLOBO-H POSITIVE: OBI-999-001

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Pancreatic, Esophageal, Gastric, Colorectal, Breast, Lung, Prostate, Melanoma, Head and Neck, Sarcoma, Bladder, Renal Cell, Ovarian, Endometrial, Cervical

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-999

Drug Class

Globo H targeting agent

PI

Dan Vaena, MD

Sponsor

OBI Pharma

Path

Any solid tumor

Key Eligibility Criteria Details
  • Histologically or cytologicall confirmed patients with advanced solid tumors
  • Must have documented Globo H score of at least 100 from a qualified laboratory IHC assay
  • Must have been treated with established standard-f-care therapy or physicians have determined that such established therapy is not sufficiently efficacious or patients have declined to received standard-of-care therapy
  • ECOG PS 0-1
  • Measurable disease
  • Adequate organ function
  • No known untreated CNS mets
  • No significant clinical cardiac abnormality
METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, metastatic solid malignancy
  • Has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior PD-1/PD-L1 allowed
  • No other malignancy within 2 years prior
  • No active autoimmune disease requiring systemic therapy within last 2 years
  • No chronic steroids or immunosuppressants.
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