Advanced Solid Tumors or LymphomasPhase 1NCT02812875
A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas
A Phase 1 study testing CA-170 in people with Advanced Solid Tumors or Lymphomas, run by Curis, Inc. at 20 sites in 4 countries.
Trial summary
CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors or Lymphomas
- What is being tested?
- CA-170
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 20 sitesin 4 countries
- Study dates
- May 2016to 7 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Males and females ≥ 18 years of age;
- Life expectancy of at least 3 months;
- ECOG PS ≤ 1;
- Acceptable bone marrow and organ function at screening;
- Ability to swallow and retain oral medications;
- Negative serum pregnancy test in women of childbearing potential;
- Measurable disease;
- Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective. For patients enrolling into backfill of dose levels at or below the MTD/RP2D, patients with tumor types known to have a high VISTA expression (such as metastatic malignant pleural mesothelioma of epithelioid histology).
Who cannot join
- Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
- Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
- Radiotherapy within the last 21 days;
- Primary brain tumors or CNS metastases;
- Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
- Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
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- Endocrinopathies, unless on stable hormone replacement therapy;
- Active infection requiring systemic therapy;
- Receipt of live vaccines against infectious diseases within 28 days;
- HIV positive or an AIDS-related illness;
- Active/chronic HBV or HCV infection;
- Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
- Cardiac dysrhythmias;
- Gastrointestinal disease that interferes with receipt of oral drugs;
- Concomitant malignancy;
- Pregnant or lactating female;
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States11 sites
Northwestern University
Chicago, Illinois, 60208
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15237
University of California San Francisco
San Francisco, California, 94143
Sarah Cannon Research Institute
Sarasota, Florida, 34232
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
Yonsei University Health System - Severance Hospital
Seoul, 3722
Asan Medical Center
Seoul, 5505
Spain3 sites
Hospital Clinic i Provincial
Barcelona, 08036
Catalan Institute of Oncology
Barcelona, 08907
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom2 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: A Phase 1, Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CA-170 in Patients With Advanced Tumors and Lymphomas
CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.
- Conditions
- Advanced Solid Tumors or Lymphomas
- Being tested
- CA-170
- Keywords
- Mesothelioma, PD-L1, VISTA, PD-1
- Medical subject headings
- Lymphoma, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-170Drug
Dose escalation stage (Phase 1a) accelerated titration and standard 3+3 dose escalation in patients with advanced solid tumor or lymphoma.
Dose expansion stage (Phase 1b) in patients with tumors that are shown to be responsive to anti-PD-1 or anti-PD-L1 checkpoint inhibitors and/or in tumor types known to express PD-L1 or VISTA, including but not limited to: mesothelioma, melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, triple negative breast cancer, head and neck cancer, colorectal cancer, gastric cancer, bladder cancer, and ovarian cancer.
| Study group | Role | What they receive |
|---|---|---|
| CA-170 | Experimental | Taken orally in a once or twice daily schedule. Receives: Drug: CA-170 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle
Measured: Approximately 24 months
Maximum tolerated dose (MTD) of CA-170
Measured: Approximately 24 months
Recommended Phase 2 Dose (RP2D) of CA-170
Measured: Approximately 24 months
Secondary outcomes (3)
Pharmacokinetic (PK) Profile of CA-170
Maximum Concentration (Cmax)
Measured: From Day 1 of Cycle 1(each cycle is 21 days)
Pharmacokinetic (PK) Profile of CA-170
Area Under the Curve (AUC)
Measured: From Day 1 of Cycle 1(each cycle is 21 days)
Preliminary Anti-tumor Activity of CA-170 based on RECIST and Immune Related Response Criterion (irRC) for Solid Tumors or Cheson for Lymphoma
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion7 May 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid Tumors or LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812875
- Sponsor's protocol ID
- CA-170-101
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2016
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zong L, Mo S, Sun Z, Lu Z, Yu S, Chen J, Xiang Y. Analysis of the immune checkpoint V-domain Ig-containing suppressor of T-cell activation (VISTA) in endometrial cancer. Mod Pathol. 2022 Feb;35(2):266-273. doi: 10.1038/s41379-021-00901-y. Epub 2021 Sep 7.
PubMed 34493823Li K, Tian H. Development of small-molecule immune checkpoint inhibitors of PD-1/PD-L1 as a new therapeutic strategy for tumour immunotherapy. J Drug Target. 2019 Mar;27(3):244-256. doi: 10.1080/1061186X.2018.1440400. Epub 2018 Feb 20.
PubMed 29448849
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CA-170 in Patients With Advanced Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT02812875
- Acronym / sponsor ID
- CA-170-101
- Conditions
- Advanced Solid Tumors or Lymphomas
- Keywords
- Mesothelioma, PD-L1, VISTA, PD-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Curis, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CA-170 | Experimental | Drug: CA-170Taken orally in a once or twice daily schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥ 18 years of age;
- Life expectancy of at least 3 months;
- ECOG PS ≤ 1;
- Acceptable bone marrow and organ function at screening;
- Ability to swallow and retain oral medications;
Key exclusion criteria (16 listed)
- Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
- Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
- Radiotherapy within the last 21 days;
- Primary brain tumors or CNS metastases;
- Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA-170Dose escalation stage (Phase 1a) accelerated titration and standard 3+3 dose escalation in patients with advanced solid tumor or lymphoma. Dose expansion stage (Phase 1b) in patients with tumors that are shown to be responsive to anti-PD-1 or anti-PD-L1 checkpoint inhibitors and/or in tumor types known to express PD-L1 or VISTA, including but not limited to: mesothelioma, melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, triple negative breast cancer, head and neck cancer, colorectal cancer, gastric cancer, bladder cancer, and ovarian cancer. | Drug | CA-170 |
Primary outcome
The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle
Time frame: Approximately 24 months
Maximum tolerated dose (MTD) of CA-170
Time frame: Approximately 24 months
Recommended Phase 2 Dose (RP2D) of CA-170
Time frame: Approximately 24 months
3 secondary outcomes
Pharmacokinetic (PK) Profile of CA-170
Time frame: From Day 1 of Cycle 1(each cycle is 21 days)
Pharmacokinetic (PK) Profile of CA-170
Time frame: From Day 1 of Cycle 1(each cycle is 21 days)
Preliminary Anti-tumor Activity of CA-170 based on RECIST and Immune Related Response Criterion (irRC) for Solid Tumors or Cheson for Lymphoma
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 34493823Zong L, Mo S, Sun Z, Lu Z, Yu S, Chen J, Xiang Y. Analysis of the immune checkpoint V-domain Ig-containing suppressor of T-cell activation (VISTA) in endometrial cancer. Mod Pathol. 2022 Feb;35(2):266-273. doi: 10.1038/s41379-021-00901-y. Epub 2021 Sep 7.
- Derived from this study: PubMed 29448849Li K, Tian H. Development of small-molecule immune checkpoint inhibitors of PD-1/PD-L1 as a new therapeutic strategy for tumour immunotherapy. J Drug Target. 2019 Mar;27(3):244-256. doi: 10.1080/1061186X.2018.1440400. Epub 2018 Feb 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CA-170 in people with Advanced Solid Tumors or Lymphomas, run by Curis, Inc. at 20 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, South Korea, Spain, United Kingdom. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle (time frame: Approximately 24 months). 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 NCT02812875, 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 26 Jun 2020.