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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

Primary Purpose

Advanced Ovarian Carcinoma, Advanced Renal Cell Carcinoma, Advanced Pancreatic Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
OATD-02
Sponsored by
Molecure S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Ovarian Carcinoma focused on measuring solid tumors, renal cancer, ovarian cancer, pancreatic cancer, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Capable of understanding and complying with protocol requirements. Male or female patient aged ≥18 years at Screening. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 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). Written informed consent given by the patient before the initiation of any study procedures. Exclusion Criteria: Unable to take oral medications. Clinically active central nervous system metastases and/or carcinomatous meningitis. Major surgery within 30 days before the first IMP dose. Pregnant or breastfeeding women. Known allergy to excipients of the IMP. 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. Participation in another clinical study within 4 weeks before the first IMP dose.

Sites / Locations

  • SiteRecruiting
  • SiteRecruiting
  • SIteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OATD-02

Arm Description

Outcomes

Primary Outcome Measures

Nature, frequency and severity of adverse events (AEs)
Occurence of DLTs

Secondary Outcome Measures

PK parameters for OATD-02: CMax
Anti-tumour activity parameters (Objective Response Rate (ORR), Duration of Response (DoR), PFS (Progression Free Survival) followed up to the End of Study Visit
PK parameter: Tmax
PK parameter Cmin
PK parameter: AUCO-24

Full Information

First Posted
February 9, 2023
Last Updated
March 7, 2023
Sponsor
Molecure S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05759923
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecure S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
solid tumors, renal cancer, ovarian cancer, pancreatic cancer, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OATD-02
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OATD-02
Intervention Description
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
Primary Outcome Measure Information:
Title
Nature, frequency and severity of adverse events (AEs)
Time Frame
6 months
Title
Occurence of DLTs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PK parameters for OATD-02: CMax
Time Frame
6 months
Title
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
Title
PK parameter: Tmax
Time Frame
6 months
Title
PK parameter Cmin
Time Frame
6 months
Title
PK parameter: AUCO-24
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of understanding and complying with protocol requirements. Male or female patient aged ≥18 years at Screening. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 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). Written informed consent given by the patient before the initiation of any study procedures. Exclusion Criteria: Unable to take oral medications. Clinically active central nervous system metastases and/or carcinomatous meningitis. Major surgery within 30 days before the first IMP dose. Pregnant or breastfeeding women. Known allergy to excipients of the IMP. 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. Participation in another clinical study within 4 weeks before the first IMP dose.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical
Phone
0048225526724
Email
clinical@molecure.com
First Name & Middle Initial & Last Name or Official Title & Degree
Molecure SA
Phone
0048225526724
Email
contact@molecure.com
Facility Information:
Facility Name
Site
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
SIte
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01748
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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