Ongoing and Planned Clinical Trials

Ongoing

Planned

  • EMERGE – Phase II of 4SC-202 in combination with an anti-PD-L1 antibody in microsatellite-stable gastrointestinal tumors

RESMAIN – Resminostat versus placebo as maintenance therapy in cutaneous T‑cell lymphoma (CTCL)

The pivotal RESMAIN study is a multi-national, multi-center, double-blind, randomized and placebo controlled study to evaluate resminostat for maintenance treatment of patients with advanced stage (Stage IIB‑IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy.

Recruitment status Recruiting
Study phase Phase II
Enrollment 150
Primary objective
  • Determine whether maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB IVB) MF or SS that have achieved disease control (complete response (CR), partial response (PR) or stable disease (SD)) with previous systemic therapy
Key secondary objective
  • Determine whether maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo

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SENSITIZE – 4SC-202 + pembrolizumab (Keytruda®, Merck) in patients with unresectable advanced-stage melanoma refractory or non-responding to prior anti-PD-1 treatment

The SENSITIZE study is an open-label, multi-center, Phase Ib/II study to evaluate the combination treatment of 4SC-202 with the anti-PD-1 antibody pembrolizumab (Keytruda®, Merck) in patients suffering from advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies.

Recruitment status Recruiting
Study phase Phase Ib/II
Enrollment 40
Primary objective
  • Determine the safety and tolerability of 4SC-202 in combination with pembrolizumab
Key secondary objective
  • Objective response rate (ORR)
  • Best overall response (BOR)
  • Disease control rate (DCR)
  • Duration of response (DOR)
  • Progression free survival (PFS)
  • Overall survival (OS)
Exploratory objective
  • Comprehensive biomarker program

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Resminostat monotherapy and S-1/resminostat combination therapy in biliary tract or pancreatic cancer

This is an open-label, dose escalation Phase I study to evaluate the dose-limiting toxicities (DLTs) of resminostat monotherapy and S-1/resminostat combination therapy in Japanese patients with unresectable/recurrent biliary tract or pancreatic cancer to determine the recommended dose regimen/s to be used in subsequent Phase II trials conducted by our cooperation partner Yakult Honsha.

Recruitment status Active, not recruiting
Study phase Phase I
Enrollment Up to 44
Primary objective
  • Evaluate the dose-limiting toxicities (DLTs) of resminostat monotherapy and S-1/resminostat combination therapy in Japanese patients with unresectable/recurrent biliary tract or pancreatic cancer
Key secondary objective
  • Assess safety and pharmacokinetics
  • Assess efficacy endpoints, such as best overall response (OR), progression free survival (PFS), overall survival (OS)

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