A Study of KC1036 in Patients with Advanced Solid Tumors

Official title

A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors

Overview

The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.

Interventions

• Drug KC1036
  Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.

Primary outcome measures

• Maximum tolerated dose (MTD) [Time frame: First 4 weeks after initial administration of KC1036]
• Adverse events (AEs) [Time frame: From enrollment up to 30 days after last dose]

Secondary outcome measures (9)

• Pharmacokinetics (PK) profile: Cmax [Time frame: First 4 weeks after initial administration of KC1036]
• Pharmacokinetics (PK) profile: Tmax [Time frame: First 4 weeks after initial administration of KC1036]
• Pharmacokinetics (PK) profile: T1/2 [Time frame: First 4 weeks after initial administration of KC1036]
• Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞ [Time frame: First 4 weeks after initial administration of KC1036]
• Objective Response Rate (ORR) [Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Progression-free survival (PFS) [Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Disease Control Rate (DCR) [Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Duration of Response (DOR) [Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Overall Survival (OS) [Time frame: From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]]

Eligibility criteria

Inclusion criteria

• Histologically or cytologically confirmed recurrent or metastatic solid tumors;
• Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy:

Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;

• At least one measurable lesion (by RECIST 1.1);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion criteria

• Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
• Other kinds of malignancies;
• Hematologic, renal, and hepatic function abnormities;
• Risk of bleeding;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
• Involved in other clinical trials within 4 weeks of enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
• History of organ allograft;
• Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
• Uncontrolled ongoing or active infection;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Suffering from mental and neurological diseases;
• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
• Inability to comply with protocol required procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 3 centers

• ChongQing University Cancer Hospital — Chongqing
• The First Affiliated Hospital of Hainan Medical University — Haikou
• West China Hospital — Chengdu

Identifiers

NCT: NCT04387916 · KC1036-I-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗