PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
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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: NCT03543813 |
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Recruitment Status :
Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : February 23, 2023
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The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma [EAC], esophageal squamous cell carcinoma [ESCC], or gastroesophageal [GE] junction) cancer.
PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumor, Adult Head and Neck Cancer Non Small Cell Lung Cancer Diffuse Large B Cell Lymphoma Esophageal Cancer | Drug: CX-2029 | Phase 1 Phase 2 |
This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy.
The study is divided into 3 parts (arms), as follows:
- Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D)
- Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A
- Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1-2, First-in-Human Study of CX-2029 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029) |
| Actual Study Start Date : | June 15, 2018 |
| Estimated Primary Completion Date : | April 30, 2023 |
| Estimated Study Completion Date : | April 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: CX-2029 Escalation
Dose Escalation and Determination
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Drug: CX-2029
CX-2029 Monotherapy |
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Experimental: CX-2029 Biomarker
Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
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Drug: CX-2029
CX-2029 Monotherapy |
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Experimental: CX-2029 Expansion
Evaluate antitumor activity of CX-2029
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Drug: CX-2029
CX-2029 Monotherapy |
- The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy [ Time Frame: 21 days (dose-limiting toxicity period) ]
- The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy [ Time Frame: 2 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
- Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment
- Agreement to provide mandatory archival tissue or fresh biopsy
- At least 18 years of age
- For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
- For Arms B and C, histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology only), or esophageal (EAC, ESCC, or GE junction) cancer
- Additional inclusion criteria may apply
Exclusion Criteria:
- Neuropathy > Grade 1
- Serious concurrent illness, including clinically relevant active infection
- Clinically significant iron metabolism disorders (eg, sickle cell anemia)
- Significant cardiac disease such as recent myocardial infarction
- History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
- Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
- History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
- Currently receiving anticoagulation therapy with warfarin;
- Major surgery (requiring general anesthesia) within 3 months prior to dosing.
- Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
- Transfusion dependent anemia with transfusion dependency of ≥3 months
- Use of iron chelators
- Additional exclusion criteria may apply
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): NCT03543813
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| Study Director: | Monika Vainorius, M.D. | CytomX Therapeutics, Inc. |
| Responsible Party: | CytomX Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03543813 |
| Other Study ID Numbers: |
CTMX-M-2029-001 |
| First Posted: | June 1, 2018 Key Record Dates |
| Last Update Posted: | February 23, 2023 |
| Last Verified: | February 2023 |
| 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 |
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cancer solid tumor DLBCL CX-2029 PROBODY™ Therapeutic |
Drug Conjugate Antibody drug conjugate CD71 Transferrin receptor 1 |
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Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin CX-2029 Immunoconjugates Immunologic Factors Physiological Effects of Drugs |