Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors (melanoma, colorectal cancer [CRC], hepatocellular carcinoma [HCC]) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Official Title

An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors

Keywords

Melanoma Carcinoma, Hepatocellular Colorectal Neoplasms metastatic or unresectable melanoma metastatic or unresectable hepatocellular carcinoma metastatic or unresectable colorectal cancer Solid tumors E7386 Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female, age >=18 years at the time of informed consent
  2. Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) selected solid tumor for which prior standard systemic therapy has failed. Selected tumor types: melanoma (excluding uveal melanoma), CRC, HCC
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  4. Must have disease progression on current or since the last anticancer treatment
  5. At least one measurable lesion by computer tomography (CT) or magnetic imaging resonance (MRI) based on RECIST 1.1
  6. Adequate organ function and serum mineral level per blood work
  7. Melanoma cohort (Phase 2), participants must have:
  8. Unresectable Stage III or Stage IV melanoma, not amenable to local therapy.
  9. Received only 1 or, if known BRAF mut +ve, 2 lines of therapies prior to study enrollment and must have progressed on 1 prior BRAF inhibitor
  10. CRC cohort (Phase 2), participants must have received at least 2 prior systemic therapies in adjuvant and/or metastatic setting (not exceeding 4 lines of therapies in the metastatic setting, progressed on at least 1 prior regimen in the metastatic setting or could not tolerate standard treatment)
  11. HCC cohort (phase 2), participants must have:
  12. Barcelona Clinic Liver Cancer (BCLC) Stage B (not amenable for transarterial chemoembolization [TACE]) or Stage C and Child Pugh class A
  13. Has received only 1 prior line of systemic therapy in the locally advanced or metastatic setting, and must have progressed on treatment with an anti-PD-1/L1 monoclonal antibodies (mAb) administered either as monotherapy, or in combination

You CAN'T join if...

  1. Prior treatment with E7386 or prior therapy with 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 (example, CTLA-4, OX 40, CD137) that was discontinued due to a Grade 3 or higher immune-related (ir)AE
  2. Participants with brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study
  3. Any active infection requiring systemic treatment
  4. Has severe hypersensitivity to study drugs and/or any of its excipients
  5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  6. Has an active autoimmune disease that has required systemic treatment in the past 2 years
  7. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  8. Any bone disease/conditions as follows:
  9. Osteoporosis with T-score <-2.5 by DXA scan
  10. Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
  11. Symptomatic hypercalcemia requiring bisphosphonate therapy
  12. History of any fracture within 6 months prior to starting study drug
  13. History of symptomatic vertebral fragility fracture or any fragility fracture
  14. Moderate or severe morphometric vertebral fracture at baseline.
  15. Any condition requiring orthopedic intervention.
  16. Bone metastases not being treated with a bisphosphonate or denosumab
  17. Active viral hepatitis (B or C) as demonstrated by positive serology for participants with melanoma and CRC. Dual active hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection at study entry for participants with HCC
  18. . Known to be human immunodeficiency virus (HIV) positive
  19. . Received blood/platelet transfusion or G-CSF within 4 weeks before study entry
  20. . For Melanoma only, participants with ocular melanoma are excluded
  21. . For CRC only, participants are excluded if:
  22. has a tumor that is microsatellite instability high (MSI H)/ DNA mismatch repair-deficient (dMMR) positive
  23. has received prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  24. . For HCC only, participants are excluded if:
  25. clear invasion to bile duct or portal vein invasion of Vp4
  26. symptomatic gastric or esophageal varices per Investigator's clinical judgement
  27. history of hepatic encephalopathy within 6 months prior to starting study drug

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90024 United States
  • Eisai Trial Site 4 accepting new patients
    Chiba-shi Japan
  • Eisai Trial Site 1 accepting new patients
    Kashiwa Japan
  • Eisai Trial Site 3 accepting new patients
    Osaka Japan
  • Eisai Trial Site 2 accepting new patients
    Tokyo Japan

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eisai Inc.
ID
NCT05091346
Phase
Phase 1/2 research study
Study Type
Interventional
Last Updated