PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03706274 |
Recruitment Status :
Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : July 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor, Adult | Drug: CX-188 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors |
Estimated Study Start Date : | January 2020 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: CX-188 Escalation |
Drug: CX-188
CX-188 |
Experimental: CX-188 Alternative Dosing Schedule |
Drug: CX-188
CX-188 |
- The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy [ Time Frame: 21 days ]
- The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy [ Time Frame: 2 years ]

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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:
- histologically confirmed diagnosis of metastatic or advanced unresectable solid tumors that progressed on standard therapy
- agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. At least 18 years old
Exclusion Criteria:
- Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
- History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
- Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
- History of or current active autoimmune diseases
- History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications
- History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
- Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
- Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug

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): NCT03706274
Contact: Gary Albert | 650-528-2929 | clinicaltrials@cytomx.com |
United States, Virginia | |
Virginia Cancer Specialists | |
Fairfax, Virginia, United States, 22031 |
Study Director: | Yifah Yaron, MD | CytomX Therapeutics |
Responsible Party: | CytomX Therapeutics |
ClinicalTrials.gov Identifier: | NCT03706274 |
Other Study ID Numbers: |
CTMX-M-188-001 |
First Posted: | October 15, 2018 Key Record Dates |
Last Update Posted: | July 30, 2019 |
Last Verified: | March 2019 |
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 |
Neoplasms |