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First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients With Selected Advanced and/or Metastatic Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05759923
Recruitment Status : Recruiting
First Posted : March 8, 2023
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Molecure S.A.

Study Description
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Brief Summary:
The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.

Condition or disease Intervention/treatment Phase
Advanced Ovarian Carcinoma Advanced Renal Cell Carcinoma Advanced Pancreatic Carcinoma Advanced Colorectal Carcinoma Metastatic Pancreatic Carcinoma Metastatic Colorectal Carcinoma Metastatic Renal Cell Carcinoma Metastatic Ovarian Carcinoma Drug: OATD-02 Phase 1

Detailed Description:

In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria.

Study scheme is based on Modified Bayesian Optimal Interval (BOIN) design.

The BOIN design works by partitioning the probability of toxicity into a set of intervals. This design makes dose-selection decisions determined by the interval in which the probability of toxicity for the current dose is believed to reside. BOIN seeks a dose with probability of toxicity close to some pre-specified target level.

Total number of patients will be 30 (plus 10 replacements if Dose Limiting Toxicity (DLT) is not evaluable).

Study treatment will be up to 6 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicentre, Dose-escalation, First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients With Selected Advanced and/or Metastatic Solid Tumours (Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)
Actual Study Start Date : January 26, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OATD-02 Drug: OATD-02
Boin Design Scheme will be applied for dose escalation. Dose will start with 2.5mg o.d., the desicion about dose escalations will be made based on the occurence of DLT


Outcome Measures
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Primary Outcome Measures :
  1. Nature, frequency and severity of adverse events (AEs) [ Time Frame: 6 months ]
  2. Occurence of DLTs [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. PK parameters for OATD-02: CMax [ Time Frame: 6 months ]
  2. Anti-tumour activity parameters (Objective Response Rate (ORR), Duration of Response (DoR), PFS (Progression Free Survival) followed up to the End of Study Visit [ Time Frame: 6 months ]
  3. PK parameter: Tmax [ Time Frame: 6 months ]
  4. PK parameter Cmin [ Time Frame: 6 months ]
  5. PK parameter: AUCO-24 [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Capable of understanding and complying with protocol requirements.
  2. Male or female patient aged ≥18 years at Screening.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  4. Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant/ineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).
  5. Written informed consent given by the patient before the initiation of any study procedures.

Exclusion Criteria:

  1. Unable to take oral medications.
  2. Clinically active central nervous system metastases and/or carcinomatous meningitis.
  3. Major surgery within 30 days before the first IMP dose.
  4. Pregnant or breastfeeding women.
  5. Known allergy to excipients of the IMP.
  6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.
  7. Participation in another clinical study within 4 weeks before the first IMP dose.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05759923


Contacts
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Contact: Clinical 0048225526724 clinical@molecure.com
Contact: Molecure SA 0048225526724 contact@molecure.com

Locations
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Poland
Site Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85796
Site Recruiting
Otwock, Mazowieckie, Poland, 05-400
SIte Recruiting
Warsaw, Mazowieckie, Poland, 01748
Sponsors and Collaborators
Molecure S.A.
More Information
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Responsible Party: Molecure S.A.
ClinicalTrials.gov Identifier: NCT05759923    
Other Study ID Numbers: OATD-02-C-01
First Posted: March 8, 2023    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molecure S.A.:
solid tumors
renal cancer
ovarian cancer
pancreatic cancer
colorectal cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Colorectal Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders