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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04794699




Registration number
NCT04794699
Ethics application status
Date submitted
9/03/2021
Date registered
12/03/2021
Date last updated
7/05/2024

Titles & IDs
Public title
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Scientific title
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
IDE397-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IDE397
Treatment: Drugs - Docetaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Sacituzumab govitecan

Experimental: Part 1: Dose Escalation Monotherapy (Solid Tumors) -

Experimental: Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial) -

Experimental: Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial) -

Experimental: Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial) -

Experimental: Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (Urothelial) -

Experimental: Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (Urothelial) -


Treatment: Drugs: IDE397
IDE397 dosed orally

Treatment: Drugs: Docetaxel
Intravenous infusion

Treatment: Drugs: Paclitaxel
Intravenous infusion

Treatment: Drugs: Sacituzumab govitecan
Intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting Toxicities (DLTs) of IDE397
Timepoint [1] 0 0
21 days following the first dose of IDE397
Primary outcome [2] 0 0
Dose-limiting Toxicities (DLTs) of IDE397 in combination with docetaxel or paclitaxel or sacituzumab govitecan
Timepoint [2] 0 0
21 - 28 days following the first dose of IDE397
Primary outcome [3] 0 0
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Timepoint [3] 0 0
Approximately 2 years
Primary outcome [4] 0 0
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with docetaxel or paclitaxel or sacituzumab govitecan
Timepoint [4] 0 0
Approximately 2 years
Primary outcome [5] 0 0
To evaluate preliminary anti-tumor activity of IDE397 in combination expansion arms
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Plasma Pharmacokinetics of IDE397 and metabolite
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Drug interaction between IDE397 and docetaxel or paclitaxel or sacituzumab govitecan
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Pharmacodynamic effect of IDE397 as a single agent and in combination with docetaxel or paclitaxel or sacituzumab govitecan
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms
Timepoint [4] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
- Participant must be at least 18 years of age

- Advanced or metastatic solid tumor that has progressed on at least one prior line of
treatment or is intolerant to additional effective standard therapy

- Have evidence of homozygous loss of MTAP or MTAP deletion

- Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions
may be made for feasibility and safety concerns

- Measurable disease

- ECOG performance status <= 1

- Adequate organ function

- Able to swallow and retain orally administered study treatment

- Recovery from acute effects of prior therapy

- Able to comply with contraceptive/barrier requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known symptomatic brain metastases

- Known primary CNS malignancy

- Current active liver or biliary disease

- Impairment of gastrointestinal (GI) function

- Active uncontrolled infection

- Clinically significant cardiac abnormalities

- Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab
govitecan

- Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry

- Radiation therapy within 2 weeks prior to study entry

- Prior irradiation to >25% of the bone marrow

- Current use or anticipated need for food or drugs that are known strong CYP3A4/5
inhibitors or inducers

- Currently receiving another investigational study drug.

- Known or suspected hypersensitivity to IDE397/excipients or components

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
14/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment postcode(s) [1] 0 0
02010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
05042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
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Michigan
Country [10] 0 0
United States of America
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New York
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United States of America
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Oklahoma
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United States of America
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Rhode Island
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United States of America
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Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux Cedex
Country [17] 0 0
France
State/province [17] 0 0
Cedex 9
Country [18] 0 0
France
State/province [18] 0 0
Marseille
Country [19] 0 0
France
State/province [19] 0 0
Rennes
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Chungcheongbuk-Do
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Gyeonggi
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
Taiwan
State/province [27] 0 0
Tainan
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
IDEAYA Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the
safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in
combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or
sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic
MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397
is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04794699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jasgit Sachdev, MD
Address 0 0
IDEAYA Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
IDEAYA Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
+1 650 534 3616
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04794699