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

ConditionsAdvanced CancerMetastatic CancerOvarian CancerPrimary Peritoneal CancerFallopian Tube CancerEndometrial CancerMetastatic Colorectal CancerPancreatic Ductal AdenocarcinomaAcinar Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtios Pharma Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent

Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.

If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated

At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)

Disqualifiers

Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment

Men who plan to father a child while in the study or within5 months after the last administration of study treatment

Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV/AIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission

Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

542 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Part A1Experimental treatment 1 intervention
Group B: Part A2Experimental treatment 2 interventions
Group C: Part A3Experimental treatment 2 interventions
Group D: Part B1Experimental treatment 2 interventions
Group E: Part B2Experimental treatment 2 interventions
Group F: Part B3Experimental treatment 1 intervention
Group G: Part B4Experimental treatment 1 intervention
Group H: Part B5Experimental treatment 2 interventions
Group I: Part B6Experimental treatment 2 interventions
Group J: Part A3 Fed/FastExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.
2

Parts B1/B3/B4: Number of participants with adverse events following administration of ART0380 monotherapy and/or in combination with irinotecan at RP2Ds.

Safety reported as incidence of adverse events

Time frame
From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380. Each cycle is 21 days.
3

Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone

Progression free survival (PFS)

Time frame
Every 6 weeks from Cycle 1 Day 1 for 18 weeks, then every 9 weeks up to approximately 24 months. Each cycle is 21 days.
4

Parts B5/B6: Object Response Rate (ORR) based on RECIST 1.1 to access anti-tumor activity of ART0380 in combination with irinotecan in each cohort.

Objective Response Rate (ORR)

Time frame
Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each Cycle is 21 days.

Secondary outcomes

1

Part B2: Number of participants with adverse events following administration of ART0380 in combination with gemcitabine or gemcitabine alone

Time frame
From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380 or gemcitabine. Each cycle is 21 days.
2

Part B5/B6: Number of participants with adverse events following administration of ART0380 at the RP2D in combination with irinotecan.

Time frame
From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380 or irinotecan. Each cycle is 21 days.
3

Pharmacokinetic Analysis (single dose): determine the plasma concentration of ART0380 when given alone and in combination

Time frame
PK will be measured at each cycle from Cycle 0 to Cycle 4. Each cycle is 21 days.
4

Pharmacokinetic Analysis (multiple dose): determine the plasma concentration of ART0380 when given alone and in combination

Time frame
PK will be measured at each cycle from Cycle 0 to Cycle 4. Each cycle is 21 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Artios Pharma Ltd

Lead sponsor

Source ClinicalTrials.gov
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