Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06974110




Registration number
NCT06974110
Ethics application status
Date submitted
2/05/2025
Date registered
15/05/2025
Date last updated
15/09/2025

Titles & IDs
Public title
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
MOMA-341-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Endometrial Cancer 0 0
MSI-H Cancer 0 0
Colorectal Cancer 0 0
Gastric Cancer 0 0
dMMR Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MOMA-341
Treatment: Drugs - Irinotecan
Treatment: Drugs - Immunotherapy

Experimental: MOMA-341 Monotherapy (Treatment Arm 1) - MOMA-341 administered as a single agent in 21-day cycles

Experimental: MOMA-341 in Combination with Irinotecan (Treatment Arm 2) - MOMA-341 administered together with irinotecan in 28-day cycles

Experimental: MOMA-341 in Combination with Immunotherapy (Treatment Arm 3) - MOMA-341 administered together with immunotherapy in 21-day cycles


Treatment: Drugs: MOMA-341
MOMA-341 administered orally

Treatment: Drugs: Irinotecan
Irinotecan administered by IV infusion

Treatment: Drugs: Immunotherapy
Immunotherapy administered by IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation
Timepoint [1] 0 0
From screening until treatment discontinuation (up to 35 months)
Secondary outcome [1] 0 0
Identify the recommended phase 2 dose (RP2D)
Timepoint [1] 0 0
From screening until treatment discontinuation (up to 35 months)
Secondary outcome [2] 0 0
PK parameter; area under curve (AUC) of MOMA-341
Timepoint [2] 0 0
Up to 6 weeks with sparse sampling up to 35 months
Secondary outcome [3] 0 0
PK parameter; maximum concentration (Cmax) of MOMA-341
Timepoint [3] 0 0
Up to 6 weeks with sparse sampling up to 35 months
Secondary outcome [4] 0 0
PK parameter; time to maximum concentration (Tmax) of MOMA-341
Timepoint [4] 0 0
Up to 6 weeks with sparse sampling up to 35 months
Secondary outcome [5] 0 0
PK parameter; half-life (T1/2) of MOMA-341
Timepoint [5] 0 0
Up to 6 weeks with sparse sampling up to 35 months
Secondary outcome [6] 0 0
PK parameter; plasma exposure of irinotecan
Timepoint [6] 0 0
Up to 6 weeks with sparse sampling up to 35 months
Secondary outcome [7] 0 0
Objective response rate (ORR)
Timepoint [7] 0 0
Up to 35 months
Secondary outcome [8] 0 0
Duration of response (DOR)
Timepoint [8] 0 0
Up to 35 months
Secondary outcome [9] 0 0
Time to response (TTR)
Timepoint [9] 0 0
Up to 35 months
Secondary outcome [10] 0 0
Progression free survival (PFS)
Timepoint [10] 0 0
Up to 35 months
Secondary outcome [11] 0 0
Disease control rate (DCR)
Timepoint [11] 0 0
Up to 35 months
Secondary outcome [12] 0 0
Overall survival (OS)
Timepoint [12] 0 0
Up to 35 months

Eligibility
Key inclusion criteria
1. Age = 18 years
2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies
3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
4. ECOG PS = 2
5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery **hormonal therapy allowed. Palliative radiotherapy allowed
6. Adequate organ function per local labs
7. Comply with contraception requirements
8. Written informed consent must be obtained according to local guidelines
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known Werner Syndrome
2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
3. Clinically relevant cardiovascular disease
4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
5. Known active uncontrolled infection
6. Known allergy, hypersensitivity, and/or intolerance to MOMA-341
7. Impaired GI function that may impact absorption
8. Patient is pregnant or breastfeeding
9. Known to be HIV positive, unless all of the following criteria are met:

1. Undetectable viral load or CD4+ count =300 cells/µL
2. Receiving highly active antiretroviral therapy
3. No AIDS-related illness within the past 12 months
10. Active liver disease (some exceptions are allowed)
11. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and/or interfere with the patients participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Investigative Site #122 - Sydney
Recruitment hospital [2] 0 0
Investigative Site #123 - Westmead
Recruitment hospital [3] 0 0
Investigative Site #124 - Woolloongabba
Recruitment hospital [4] 0 0
Investigative Site #125 - Adelaide
Recruitment hospital [5] 0 0
Investigative Site #126 - Clayton
Recruitment hospital [6] 0 0
Investigative Site #119 - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MOMA Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
MOMA Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
857-285-3677
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06974110