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Monoclonal Antibodies

ARX788 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Ambrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Summary

This trial will help find the best dose of a new cancer drug, ARX788, and assess how well it works against HER2 positive breast, gastric, and other solid tumors.

Eligible Conditions
  • Breast Cancer
  • Gastric Neoplasm
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects experiencing adverse events, frequency and seriousness of treatment emergent adverse events (TEAEs)
Phase 1b: Objective response rate (ORR: complete response + partial response) per imaging assessment based on RECIST version 1.1.
Secondary outcome measures
Area under the concentration-time curve (AUC) from first infusion to subject end of study.
Half-life of ARX788 from first infusion to end of study.
Immunogenicity profile of ARX788
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 331 Patients • NCT02257567
67%
FATIGUE
50%
ALOPECIA
50%
DECREASED APPETITE
50%
CONSTIPATION
50%
NAUSEA
50%
INSOMNIA
33%
HYPOPHOSPHATAEMIA
33%
RASH
33%
NEUTROPENIA
33%
VOMITING
33%
NIGHT SWEATS
33%
DIARRHOEA
33%
WEIGHT DECREASED
33%
HYPERGLYCAEMIA
33%
DYSPNOEA
17%
PRURITUS
17%
FOLLICULITIS
17%
CHILLS
17%
STOMATITIS
17%
SKIN DISCOLOURATION
17%
HYPERTENSION
17%
PLATELET COUNT DECREASED
17%
GLAUCOMA
17%
THROMBOCYTOPENIA
17%
ARTHROPOD BITE
17%
BONE PAIN
17%
HERPES ZOSTER
17%
INFUSION RELATED REACTION
17%
LYMPHOCYTE COUNT DECREASED
17%
HYPOMAGNESAEMIA
17%
HYPOKALAEMIA
17%
NEUROPATHY PERIPHERAL
17%
PERIPHERAL SENSORY NEUROPATHY
17%
EYE PRURITUS
17%
VISION BLURRED
17%
FLATULENCE
17%
SINUSITIS
17%
ENDOMETRIAL ADENOCARCINOMA
17%
ENDOMETRIAL CANCER
17%
ANAEMIA
17%
ABDOMINAL PAIN
17%
MUSCULAR WEAKNESS
17%
COUGH
17%
DYSPNOEA EXERTIONAL
17%
DRY SKIN
17%
MOUTH ULCERATION
17%
PALLOR
17%
EYE DISCHARGE
17%
VITAMIN D DEFICIENCY
17%
SINUS CONGESTION
17%
ATRIAL FIBRILLATION
17%
PYREXIA
17%
DIZZINESS
17%
PERIPHERAL SWELLING
17%
HODGKIN'S DISEASE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
Arm A (Phase II Randomization): Pola+BR in FL
Arm B (Phase II Randomization): BR in FL
Arm C (Phase II Randomization): Pola+BR in DLBCL
Arm D (Phase II Randomization): BR in DLBCL
Arm E (Phase II Expansion): Pola+BG in FL
Arm F (Phase II Expansion): Pola+BG in DLBCL
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

Trial Design

2Treatment groups
Experimental Treatment
Group I: ARX788 Phase 1b (Dose Expansion)Experimental Treatment1 Intervention
ARX788 will be administered every 3 weeks (Q3W) via intravenous (IV) infusion. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.
Group II: ARX788 Phase 1a (Dose Escalation)Experimental Treatment1 Intervention
ARX788 will be administered every 3 weeks (Q3W) or every 4 weeks (Q4W) via intravenous (IV) infusion. Patients will be enrolled into escalating dose levels during Dose Escalation period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARX788
2018
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Ambrx, Inc.Lead Sponsor
7 Previous Clinical Trials
664 Total Patients Enrolled
AmbrxStudy DirectorAmbrx, Inc.
2 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

ARX788 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03255070 — Phase 1
~14 spots leftby Jul 2025
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