Study of TRX-920 for Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-100

SponsorTaiRx, Inc.

About this trial

The study drug TRX-920 Oral Gel contains SN38, an active metabolite of Irinotecan (CPT-11), which is a widely prescribed anti-cancer drug that has been approved in many countries for the treatment of colorectal and pancreatic cancer. TRX-920 is the oral gel formulation that directly contains SN38 instead of Irinotecan. A series of biology and animal studies have demonstrated that the TRX-920 Oral Gel could inhibit tumor growth with fewer side effects compared to Irinotecan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and dated informed consent form

Histologically and cytologically confirmed advanced solid tumor malignancies that are refractory to standard therapy or have no accepted standard therapy.

Solid tumors that are measurable or evaluable as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion).

Female or male, 18 years of age or older.

Disqualifiers

Patients with homozygous or compound heterozygous genotypes for UGT1A1*28 and *6 alleles (e.g., *28/*28, *6/*6, *6/*28).

Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (>160/100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.

Acute myocardial infraction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.

Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.

Trial design

Design model

Single group

Treatments tested in this trial

TRX-920 Oral Gel (10 mg and 30 mg)
Drug
TRX-920 Oral Gel will be administered orally at a week (BIW) in an 8-week cycle. No food should be taken 2 hours before and 1 hour after taking TRX-920. The dose escalation/de-escalation rules will be based on definitions of dose-limiting toxicity (DLT) and will be monitored during the first treatment cycle (i.e., the first 4 weeks post the first dose). The starting dose will be 1 mg and the dosing frequency is twice every week (BIW). Subjects will be assigned to a dose level in sequential cohorts based on the order of their enrollment. The dose escalation will follow a 3+3 design and doses escalate from approximately 1 mg BIW, 2 mg BIW, 4 mg BIW, 8 mg BIW, and 16mg BIW and the doses for subsequent cohorts will be determined by Safety Review Committee (SRC). Dose escalation will be stopped till the maximum tolerated dose (MTD) is reached or identified.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: TRX-920 Oral GelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TRX-920 Oral Gel

The MTD is defined as the highest dose level at which no more than 1 in 6 subjects experiences a DLT. The recommended Phase 2 dose (RP2D) will be determined by Safety Review Committee based on all available PK, safety, and preliminary efficacy data. The RP2D will not exceed the MTD.

Time frame

the first 4 weeks post the first dose

Frequency, type, severity and relationship to study drug of adverse events (AEs) of TRX-920 Oral Gel

AEs will be coded by system organ class (SOC) and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) system.

Time frame