A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Conditions

• Acinar Cell Carcinoma
• Advanced Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Metastatic Cancer
• Metastatic Colorectal Cancer
• Ovarian Cancer
• Pancreatic Ductal Adenocarcinoma
• Primary Peritoneal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ART0380 — DRUG
  Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
• Gemcitabine — DRUG
  Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle.
• Irinotecan — DRUG
  Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.

Study Details

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan

Key Dates

Start date

Jan 27, 2021

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

442 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A1
  Part A1 evaluated intermittent and continuous dosing of ART0380 monotherapy. Treatment was given in 21-day cycles.
• Experimental: Part A2
  Part A2 evaluated intermittent dosing of ART0380 in combination with gemcitabine in 21-day cycles.
• Experimental: Part A3
  Part A3 evaluated intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles.
• Experimental: Part B1
  In Part B1, up to 7 cohorts enrolled participants with solid cancers with alterations in the ATM (ataxia-telangiectasia mutated) gene likely to predict for loss of ATM protein will be treated with either * ART0380 monotherapy Or * ART0380 in combination with irinotecan
• Experimental: Part B2
  In Part B2, participants with high grade serous ovarian, primary peritoneal, or fallopian tube carcinoma were randomized (open label) 1:1 to either ART0380 in combination with gemcitabine or gemcitabine alone.
• Experimental: Part B3
  in Part B3, participants with persistent or recurrent endometrial cancer (EC) received ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.
• Experimental: Part B4
  In Part B4, participants with advanced or metastatic solid tumors received ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.
• Experimental: Part B5
  In Part B5, participants with colorectal cancer (CRC) will receive ART0380 in combination with irinotecan on a 21-day cycle.
• Experimental: Part B6
  In Part B6, participants with pancreatic ductal adenocarcinoma (PDAC) or acinar cell carcinoma will receive ART0380 in combination with irinotecan on a 21-day cycle.
• Experimental: Part A3 Fed/Fast
  Part A3 Fed/Fast will evaluate intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles in a fasting or fed state.

Primary Outcome Measure

Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from ART0380 monotherapy and in combination with gemcitabine or irinotecan [ Time Frame: From Cycle 0 Day -2 to Cycle 1 Day 21. Each cycle is 21 days. ]

Central Contacts

• Sarah Cannon Development Innovations
  844-710-6157
  [email protected]

Locations (40)

Find similar trials in Birmingham, AL

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