Trial record 1 of 1 for:
NCT04585035
Study to Evaluate D-1553 in Subjects With Solid Tumors
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04585035 |
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Recruitment Status :
Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : April 9, 2024
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Sponsor:
InventisBio Co., Ltd
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
InventisBio Co., Ltd
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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: D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 180 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 : | April 15, 2024 |
| Estimated Study Completion Date : | February 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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: D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other Standard treatment of solid tumor, NSCLC or CRC |
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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.
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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: D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other Standard treatment of solid tumor, NSCLC or CRC |
Primary Outcome Measures :
- Subject incidence of Dose-limiting toxicities (DLT) [ Time Frame: through out the DLT period, approximately 21 days ]
- Number of subjects participants with adverse events [ Time Frame: Through study completion, approximately 3 years ]
- 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 |
Criteria
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 bio-specimens 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
Locations
| United States, California | |
| Research Site | |
| Fresno, California, United States, 93720 | |
| Research Site | |
| Orange, California, United States, 92868 | |
| Research Site | |
| San Francisco, California, United States, 94158 | |
| United States, Kentucky | |
| Research Site | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Research Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Research Site | |
| New York, New York, United States, 11432 | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States, 97213 | |
| Australia, New South Wales | |
| Research Site | |
| Blacktown, New South Wales, Australia, 2148 | |
| Research Site | |
| East Albury, New South Wales, Australia, 2640 | |
| Research Site | |
| Kogarah, New South Wales, Australia, 2217 | |
| Research Site | |
| Waratah, New South Wales, Australia, 2298 | |
| Australia, South Australia | |
| Research Site | |
| Woodville South, South Australia, Australia, 5011 | |
| Australia, Victoria | |
| Research Site | |
| Fitzroy, Victoria, Australia, 3065 | |
| Research Site | |
| Frankston, Victoria, Australia, 3199 | |
| Research Site | |
| Malvern, Victoria, Australia, 3144 | |
| Australia, Western Australia | |
| Research Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Korea, Republic of | |
| Research Site | |
| Seogu, Busan, Korea, Republic of, 602-715 | |
| Research Site | |
| Seongnam-si, Gyeonggi-Do, Korea, Republic of, 463-707 | |
| Research Site | |
| Seoul, Korea, Republic of, 06591 | |
| Research Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Research Site | |
| Seoul, Korea, Republic of, 152-703 | |
| Taiwan | |
| Research Site | |
| Tainan, Taiwan, 704 | |
| Research Site | |
| Taipei City, Taiwan, 10002 | |
| Research Site | |
| Taipei, Taiwan, 11217 | |
| Research Site | |
| Taoyuan City, Taiwan, 333 | |
Sponsors and Collaborators
InventisBio Co., Ltd
Merck Sharp & Dohme LLC
| Responsible Party: | InventisBio Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT04585035 |
| Other Study ID Numbers: |
D1553-101 KEYNOTE-C15 MK3475-C15 ( Other Identifier: Merck Sharpe and Dohme LLC ) |
| First Posted: | October 14, 2020 Key Record Dates |
| Last Update Posted: | April 9, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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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Neoplasms Pembrolizumab Cetuximab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |