Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors

Conditions

• Metastatic Urothelial Carcinoma
• Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SEphB4-HSA — DRUG
  A recombinant protein comprised of the soluble form of human receptor EphB4 fused to human serum albumin.
• Pembrolizumab — DRUG
  Antibody to human PD-1.
• Gemcitabine — DRUG
  A chemotherapy drug used to treat various types of cancer.
• Cisplatin — DRUG
  A type of chemotherapy drug called an alkylating agent used to treat various types of cancer.
• Enfortumab vedotin — DRUG
  Nectin-4-directed antibody and microtubule inhibitor conjugate.

Study Details

Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA. The primary objective of this study is to demonstrate additive therapeutic benefit for sEphB4-HSA. The secondary objectives are to determine whether the sEphB4-HSA containing regimen is safe and whether the oncological endpoints of importance in each cohort improve as a result of treatment with sEphB4-HSA containing regimen relative to a predefined threshold or to a control arm in the cohort where available. Treatment continues until progression of disease or unacceptable toxicities arise.

Key Dates

Start date

Mar 15, 2025

Status verified

Mar 2025

Primary completion

Sep 30, 2029

Completion

Aug 31, 2034

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: sEphB4-HSA + Pembrolizumab in MIBC
  sEphB4-HSA shall be started at a dose of 10mg/kg using actual body weight and administered IV over 60 minutes on days 1 and 8 of each cycle as outlined under section 7.1.3. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. All trial treatments will be administered on an outpatient basis unless the patient has been admitted for another reason and meets all criteria for further therapy. Pembrolizumab dose, schedule, delays, and discontinuation of therapy shall be determined by the treating physician in accordance with product label(s), standard of care and institutional policies. Treatment will continue until the prespecified number of cycle of therapy are completed or until progression of disease or unacceptable toxicities where specified by the protocol for specific cohort(s).
• Active Comparator: Gemcitabine-Cisplatin (GC) or Pembrolizumab Alone in MIBC
  Dose modification, delays and discontinuation of therapy shall be determined by the treating physician in accordance with product label(s), standard of care and institutional policies.
• Experimental: sEphB4-HSA + Pembrolizumab in Naive mUC
  sEphB4-HSA shall be started at a dose of 10mg/kg using actual body weight and administered IV over 60 minutes on days 1 and 8 of each cycle as outlined under section 7.1.3. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. All trial treatments will be administered on an outpatient basis unless the patient has been admitted for another reason and meets all criteria for further therapy. Pembrolizumab dose, schedule, delays, and discontinuation of therapy shall be determined by the treating physician in accordance with product label(s), standard of care and institutional policies. Treatment will continue until the prespecified number of cycle of therapy are completed or until progression of disease or unacceptable toxicities where specified by the protocol for specific cohort(s).
• Active Comparator: Enfortumab Vedotin (EV) + Pembrolizumab in Naive mUC
  Dose modification, delays and discontinuation of therapy shall be determined by the treating physician in accordance with product label(s), standard of care and institutional policies.

Primary Outcome Measure

Improved pathological response (pCR) in sEphB4-HSA+Pembro vs. Standard of Care for MIBC [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts

• Jon Cogan, MS
  323-221-7818
  [email protected]

Locations (1)

Find similar trials in Santa Monica, CA

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