Evaluating KC1036 for advanced solid tumors

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

This study is testing a new drug called KC1036 to see if it is safe and effective for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 207 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Chongqing, Chongqing Municipality and 2 other locations)
• Trial ID: NCT04387916 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in patients with advanced recurrent or metastatic solid tumors. It consists of three phases: a dose-escalation phase to determine the maximum tolerated dose, a dose-expansion phase to further evaluate safety and efficacy, and an RP2D-extension phase to confirm the recommended phase 2 dose. Participants must have measurable lesions and have failed prior standard treatments.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed advanced solid tumors who have progressed after standard therapies.

Not a fit: Patients with untreated brain metastases or other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While there have been studies on similar treatments, the specific approach of KC1036 in this context is novel.

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.

Where this trial is running

Chongqing, Chongqing Municipality and 2 other locations

• ChongQing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• The First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Recruiting)
• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Conditions Advanced Solid Tumors