AzTrials
AzTrials

Solid Tumor, AdultPhase 1/2NCT04585035

Study to Evaluate D-1553 in Subjects With Solid Tumors

A Phase 1/2 study testing D-1553 and D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other in people with Solid Tumor, Adult and NSCLC, run by InventisBio Co., Ltd at 25 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult, NSCLC, CRC
What is being tested?
D-1553 and D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
25 sitesin 4 countries
Study dates
2 Oct 2020to Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

25 sites in 4 countries.

25 sites in 4 countries

Australia9 sites

  • Research Site

    Blacktown, New South Wales, 2148

  • Research Site

    East Albury, New South Wales, 2640

  • Research Site

    Fitzroy, Victoria, 3065

  • Research Site

    Frankston, Victoria, 3199

  • Research Site

    Kogarah, New South Wales, 2217

  • Research Site

    Malvern, Victoria, 3144

  • Research Site

    Nedlands, Western Australia, 6009

  • Research Site

    Waratah, New South Wales, 2298

  • Research Site

    Woodville South, South Australia, 5011

Other trials in Australia

United States7 sites

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    Fresno, California, 93720

  • Research Site

    Louisville, Kentucky, 40202

  • Research Site

    New York, New York, 11432

  • Research Site

    Orange, California, 92868

  • Research Site

    Portland, Oregon, 97213

  • Research Site

    San Francisco, California, 94158

Other trials in United States

South Korea5 sites

  • Research Site

    Seogu, Busan, 602-715

  • Research Site

    Seongnam-si, Gyeonggi-do, 463-707

  • Research Site

    Seoul, 06591

  • Research Site

    Seoul, 138-736

  • Research Site

    Seoul, 152-703

Other trials in South Korea

Taiwan4 sites

  • Research Site

    Tainan, 704

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 11217

  • Research Site

    Taoyuan City, 333

Other trials in Taiwan

About this study

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

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.

Being tested
D-1553, D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D-1553Drug

    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.

  • D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: otherDrug

    Standard treatment of solid tumor, NSCLC or CRC

Study groups in NCT04585035
Study groupRoleWhat they receive
Dose escalation of D-1553 monotherapyExperimentalPhase 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.
Receives: Drug: D-1553
Dose combination of D-1553 with other therapiesExperimentalPhase 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.
Receives: Drug: D-1553; Drug: D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other
Phase 2 of D-1553 monotherapy and combination therapiesExperimentalThe 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.
Receives: Drug: D-1553; Drug: D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject incidence of Dose-limiting toxicities (DLT)

    Measured: through out the DLT period, approximately 21 days

  2. Number of subjects participants with adverse events

    Measured: 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.

    Measured: Through study completion, approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start2 Oct 2020
  3. Primary completion30 Apr 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585035
Sponsor's protocol ID
D1553-101
Other IDs
KEYNOTE-C15 MK3475-C15
Status last verified
Oct 2024
First submitted
27 Sep 2020
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yan D, Liu C, Li X, Moore M, Xu R, Sanborn RE, Gadgeel SM, Millward M, Shi Z, Wang Y, Stazzone K, Chisamore MJ, Zhang L. Garsorasib (D-1553) in Combination With Pembrolizumab and Chemotherapy for First-Line Metastatic NSCLC With KRAS G12C Mutation: Results of a Phase 1b Study. JTO Clin Res Rep. 2026 Jun 30;7(10):101037. doi: 10.1016/j.jtocrr.2026.101037. eCollection 2026 Oct.

    PubMed 42924167

  • Ruan DY, Wu HX, Xu Y, Munster PN, Deng Y, Richardson G, Yan D, Lee MA, Lee KW, Pan H, Hager S, Li X, Wei S, Hou X, Underhill C, Millward M, Nordman I, Zhang J, Shan J, Han G, Grewal J, Gadgeel SM, Sanborn RE, Huh SJ, Hu X, Zhang Y, Xiang Z, Luo L, Xie X, Shi Z, Wang Y, Zhang L, Wang F, Xu RH. Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation. Signal Transduct Target Ther. 2025 Jun 17;10(1):189. doi: 10.1038/s41392-025-02274-z.

    PubMed 40523897

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing D-1553 and D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other in people with Solid Tumor, Adult and NSCLC, run by InventisBio Co., Ltd at 25 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Australia, United States, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject incidence of Dose-limiting toxicities (DLT) (time frame: through out the DLT period, approximately 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585035, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in