Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Resistant or Refractory Solid Tumors

In brief

This is a multi-center, open-label, dose-escalation, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or refractory solid tumors.

Key facts

Study ID: NCT04686383
Run by: Calgent Biotechnology Co., Ltd
People needed: 17
Starts: 2020-12-29
Expected to finish: 2022-06-30
Last updated by the study team: 2023-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with age ≥ 18 years old
Patients with resistant or refractory solid tumors confirmed by histology which are unresponsive to standard therapies
Patients with at least one measurable lesion per RECIST version 1.1.
Patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) ≤ 2
Patients with at least 3 months of life expectancy as judged by the investigators
Patients with adequate bone marrow reserve and organ function
Patients with the negative result for testing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Female patients are eligible to participate if they are of non-childbearing potential or have documentation of a negative serum pregnancy test at screening. Sexually active pre-menopausal women of childbearing potential must agree to use adequate, highly effective contraceptive measures during and upon completion of the study and for at least 6 months after the last dose of study drug
Male patients who agree to use an adequate method of contraception during and upon completion of the study and for at least 6 months after the last dose of study drug
Patients must be willing and be able to provide written informed consent for the study.

You may not qualify if…

History of other invasive malignancy that is currently active and/or has been treated within 12 months prior to screening
Patients with the presence of symptomatic central nervous system (CNS) metastases requiring radiation treatment, surgery, or continuous use of corticosteroids or patients with untreated or developing brain metastasis causing any symptoms, such as neurologic deficits, seizures, or headache
Any prior adjuvant cytotoxic chemotherapy within 4 weeks prior to screening
Any radiotherapy within 2 weeks prior to screening
Pre-existing chemotherapy-related peripheral neuropathy
Currently participating or has participated in a study of an investigational product within 4 weeks prior to the first dose of CAL056 mesylate
Patients with history of organ or stem cell transplant requiring immunosuppressive medications
Active autoimmune disease
Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or hypersensitivity pneumonitis
Patients who have chronic obstructive pulmonary disease (COPD) or asthma
Has a history of pneumonitis that required steroids or current pneumonitis
Known significant liver disease
Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies)
Has received live attenuated vaccination within 30 days prior to the first dose of CAL056 mesylate
Female patients who is pregnant, breast-feeding, or planning to become pregnant
Patients with corrected QT interval (QTc) interval of > 450 msec.
Has history of clinically significant or severe gastrointestinal disease or condition that may affect drug absorption within the past 3 months.

Where it is running

USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
NEXT Oncology, 2829 Babcock Road Suite 300 — San Antonio, Texas, United States
Tzu Chi General Hospital, Taipei Branch — New Taipei City, Taiwan

Full record on ClinicalTrials.gov

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