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Study to Evaluate D-1553 in Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT04585035
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : March 29, 2022
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
InventisBio Co., Ltd

Brief Summary:
This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult NSCLC CRC Drug: D-1553 Drug: Other Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase Ia dose escalation portion of the study followed by a Phase Ib dose combination portion. Phase 2 will consist of 5 treatment arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: Dose escalation of D-1553 monotherapy
Phase 1a will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.
Drug: D-1553
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.

Experimental: Dose combination of D-1553 with other therapies
Phase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors. There are multiple groups in Phase 1b for different tumor types and treatment combinations to evaluate safety, MTD and RP2D.
Drug: D-1553
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.

Drug: Other
Standard treatment of solid tumor, NSCLC or CRC

Experimental: Phase 2 of D-1553 monotherapy and combination therapies
The Phase 2 portion is a multi-arm, parallel, open label study to evaluate the efficacy of D- 1553 single agent and combination treatments in subjects with advanced or metastatic solid tumors with KRas G12C mutation. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose.
Drug: D-1553
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.

Drug: Other
Standard treatment of solid tumor, NSCLC or CRC

Primary Outcome Measures :
  1. Subject incidence of Dose-limiting toxicities (DLT) [ Time Frame: through out the DLT period, approximately 21 days ]
  2. Number of subjects participants with adverse events [ Time Frame: Through study completion, approximately 3 years ]
  3. Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation. [ Time Frame: Through study completion, approximately 3 years ]

Information from the National Library of Medicine

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

Inclusion criteria

  • Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
  • Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
  • Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
  • Subject has measurable disease according to RECIST, v1.1.

Exclusion Criteria:

  • Subject with unstable or progressive central nervous system (CNS) metastases.
  • Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
  • Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
  • Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
  • Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
  • Subject has any history or evidence of substance abuse or medical, psychological or social conditions that may, in the opinion of the investigator, interfere with participation in the study or evaluation of the study results.
  • Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
  • Subject has unresolved toxicities from prior anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE, v5.0, Grade ≤ 1 (Grade ≤ 2 for peripheral neuropathy).
  • Subject had major surgery within 4 weeks prior to study intervention administration or last dose of palliative radiation therapy within 2 weeks prior to study intervention administration.
  • Subject is pregnant or lactating.

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): NCT04585035

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Contact: Jeremy Zeng (86)21-50663661 xianghu.zeng@inventisbio.com

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United States, California
Research Site Recruiting
Fresno, California, United States, 93720
Research Site Recruiting
Orange, California, United States, 92868
Research Site Recruiting
San Francisco, California, United States, 94158
United States, Kentucky
Research Site Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
Research Site Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Research Site Recruiting
New York, New York, United States, 11432
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Australia, New South Wales
Research Site Recruiting
Blacktown, New South Wales, Australia, 2148
Research Site Recruiting
East Albury, New South Wales, Australia, 2640
Research Site Not yet recruiting
Kogarah, New South Wales, Australia, 2217
Research Site Not yet recruiting
Waratah, New South Wales, Australia, 2298
Australia, South Australia
Research Site Recruiting
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Research Site Recruiting
Fitzroy, Victoria, Australia, 3065
Research Site Recruiting
Frankston, Victoria, Australia, 3199
Research Site Recruiting
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Research Site Recruiting
Nedlands, Western Australia, Australia, 6009
Korea, Republic of
Research Site Recruiting
Seo-Gu, Busan, Korea, Republic of, 602-715
Research Site Recruiting
Seongnam-si, Gyeonggi-Do, Korea, Republic of, 463-707
Research Site Recruiting
Seocho-Gu, Seoul, Korea, Republic of, 06591
Research Site Recruiting
Songpa-Gu, Seoul, Korea, Republic of, 138-736
Research Site Recruiting
Seoul, Korea, Republic of, 152-703
Research Site Recruiting
Tainan, Taiwan, 704
Research Site Recruiting
Taipei City, Taiwan, 10002
Research Site Recruiting
Taipei, Taiwan, 11217
Research Site Recruiting
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
InventisBio Co., Ltd
Merck Sharp & Dohme LLC
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Responsible Party: InventisBio Co., Ltd
ClinicalTrials.gov Identifier: NCT04585035    
Other Study ID Numbers: D1553-101
KEYNOTE-C15 ( Other Identifier: Merck Sharpe & Dohme Corp )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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