CLINICAL TRIALS

The clinical experience and well-being of the patient are central to our drug discovery effort.

Narazaciclib (ON 123300) in Patients with Advanced Solid Tumors

Phase 1 in US (NCT04739293)

This is an exploratory Phase 1 study to assess the safety, tolerability, and pharmacokinetics of narazaciclib (ON 123300) capsules administered orally as escalating daily doses in patients with advanced cancer relapsed or refractory to at least one (1) prior line of therapy.

Status: Recruiting

Sponsor:
Onconova Therapeutics, Inc.

Narazaciclib (ON 123300) Plus Letrozole in Recurrent Metastatic Low-grade Endometrioid Endometrial Cancer

Phase 1/2a (NCT05705505)

This study will assess the safety and efficacy of increasing doses of narazaciclib (ON 123300) in combination with the standard daily dose (2.5mg) of letrozole as second or third line treatment in patients with Recurrent Metastatic Low-grade Endometrioid Endometrial Cancer.

Status: Recruiting

Sponsor:
Onconova Therapeutics, Inc.

Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors

Phase 2 (NCT05764395)

This phase II clinical trial tests how well rigosertib plus pembrolizumab works in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous treatment with PD-1 or PD-L1 inhibitors (refractory).

Status: Recruiting

Sponsor:
Vanderbilt-Ingram Cancer Center

Collaborators:
Onconova Therapeutics, Inc.

Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment

Phase 1/2a (NCT04263090)

This is an open-label, Phase 1/2a study incorporating a dose-escalating stage followed by a dose-expansion stage to study the combination of rigosertib and nivolumab in metastatic Kirsten rat sarcoma positive (KRAS+) lung adenocarcinoma patients who have progressed on standard first line treatment.

Status: Recruiting

Sponsor:
Icahn School of Medicine at Mount Sinai

Collaborators:
Bristol-Myers Squibb
Onconova Therapeutics, Inc.

Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC

Phase 1 (NCT04177498)

This is a Phase 1 open study to assess efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).

Status: Recruiting

Sponsor:
Thomas Jefferson University

Collaborator:
Onconova Therapeutics, Inc.

Rigosertib in Recessive Dystrophic Epidermolysis Bullosa-Associated Squamous Cell Carcinoma

Phase 2 in Austria and England

This is a Phase 2 open study to assess efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).

Status: Recruiting

Sponsor:
Prof. Johann W. Bauer MD

Collaborators:
DEBRA International
Onconova Therapeutics, Inc.

Narazaciclib (ON 123300) in Patients with Advanced Solid Tumors

Phase 1 in China

This is an open-label, dose-escalating  Phase 1 study to study the safety and tolerability of narazaciclib (ON 123300) in patients with advanced solid tumors who have failed on prior therapies. An expansion cohort of breast and lung cancer patients will be enrolled at the recommended Phase 2 dose.

Status: Recruiting

Sponsor:
HanX BioPharmaceuticals

Collaborators:
Onconova Therapeutics, Inc.