A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors.
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ClinicalTrials.gov Identifier: NCT04242147 |
Recruitment Status :
Recruiting
First Posted : January 27, 2020
Last Update Posted : February 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumor | Drug: KD033 for Injection | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors. |
Actual Study Start Date : | June 3, 2020 |
Estimated Primary Completion Date : | November 2022 |
Estimated Study Completion Date : | March 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Monotherapy
KD033 will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W)
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Drug: KD033 for Injection
KD033 Monotherapy |
- Occurrence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to week 5 of treatment ]To evaluate the number of subjects who experienced DLTs during the dose escalation phase
- Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity [ Time Frame: Up to 90 days after last treatment ]To evaluate the number of TEAEs and related TEAEs by severity
- Maximum Tolerated Dose (MTD) [ Time Frame: Through study completion, an average of 1 year ]To determine the safety/tolerability and the MTD of subjects during the dose escalation phase
- Recommended Phase 2 Dose (RP2D) [ Time Frame: Through study completion, an average of 1 year ]To determine the RP2D during the dose expansion phase
- Best Overall Response (BOR) [ Time Frame: Through study completion, an expected average of 1 year ]To evaluate the best overall response from study treatment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria per Investigator assessment
- Duration Of Response (DOR) [ Time Frame: Through study completion, an expected average of 1 year ]To evaluate the duration of response from study treatment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria per Investigator assessment
- Changes in immune correlates in peripheral blood [ Time Frame: Through study completion, an expected average of 1 year ]To evaluate changes in immune correlates of KD033 in peripheral blood to better understand the mechanism of action
- Exploration of KD033 Pharmacokinetic (PK) Profile - Cmax [ Time Frame: Through study completion, an expected average of 1 year ]The PK profile of KD033 will be evaluated using blood samples collected during the dose escalation and dose expansion phases to determine the maximum concentration (Cmax)
- Exploration of KD033 Pharmacokinetic (PK) Profile - AUC [ Time Frame: Through study completion, an expected average of 1 year ]The PK profile of KD033 will be evaluated using blood samples collected during the dose escalation and dose expansion phases to determine area under the curve (AUC)
- Exploration of Anti-KD033 Antibodies [ Time Frame: Through study completion, an expected average of 1 year ]To evaluate serum titers and assessment of neutralization of anti-KD033 antibodies using blood samples collected during the dose escalation and dose expansion phases

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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 or cytologically confirmed/documented advanced and/or metastatic solid tumor with at least one tumor lesion of location accessible to biopsy per clinical judgement of treating physician.
- Measurable disease per RECIST v1.1 guidelines.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≤ 1.
- Adequate organ and bone marrow functions.
- All toxicities related to prior radiotherapy, chemotherapy, or surgical procedure must have recovered to baseline or Grade ≤ 1 based on NCI-CTCAE v5.0 except alopecia (any grade), Grade 2 peripheral neuropathy and adverse events that are clinically non significant or stable on supportive care.
- All subjects, male and female, who are not surgically sterilized or postmenopausal must agree to use "highly effective methods of contraception" during the study and for at least 60 days after the last dose of KD033.
Exclusion Criteria:
- Use of immunotherapy, biological therapy, cytokine therapy < 21 days prior to the first dose of study drug.
- Use of immunomodulating agents < 21 days prior to the first dose of study drug.
- Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy < 14 days prior to the first dose of study drug.
- Anti PD-L1 or anti PD-1 therapy < 6 weeks prior to the first dose of study drug.
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required systemic immunosuppressive treatments.
- Systemic therapy with immunosuppressive agents including corticosteroids within 14 days before the start of trial treatment.
- Rapidly progressive disease which, in the opinion of Investigator, may predispose to inability to tolerate treatment or trial procedure.
- History or clinical evidence of central nervous system primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, demonstrated no progression at least 1 months, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening - Subjects with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry.
- Receipt of any organ transplantation including hematopoietic cell transplantation.
- Has a paraneoplastic syndrome of autoimmune nature.
- History of interstitial lung disease or severe obstructive pulmonary disease.
- Clinically significant cardiovascular/cerebrovascular disease.
- QTc(F) interval > 450 ms for men or > 470 ms for women)
- Left ventricular ejection fraction (LVEF) < 50% as measured by an echocardiogram (ECHO).
- Active infection requiring therapy.
Other protocol-defined exclusion criteria could 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): NCT04242147
Contact: Miranda Schlitt | (724)778-6170 | miranda.schlitt@kadmon.com |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Cayla Ford 716-845-2300 ext 4924 cayla.ford@roswellpark.org | |
Principal Investigator: Igor Puzanov, MD | |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Kelsie Peta, BSN, RN 215-728-2175 Kelsie.peta@fccc.edu | |
Principal Investigator: Anthony Olszanski, MD | |
University of Pittsburgh Medical Center - Hillman Cancer Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Krystle Eaton, BSN 412-623-4511 mientkiewiczk@upmc.edu | |
Principal Investigator: Jason Luke, MD, FACP |
Responsible Party: | Kadmon Corporation, LLC |
ClinicalTrials.gov Identifier: | NCT04242147 |
Other Study ID Numbers: |
KD033-101 |
First Posted: | January 27, 2020 Key Record Dates |
Last Update Posted: | February 5, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms |