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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

Study 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%
PLATELET COUNT DECREASED
17%
PRURITUS
17%
ARTHROPOD BITE
17%
SKIN DISCOLOURATION
17%
THROMBOCYTOPENIA
17%
HYPERTENSION
17%
GLAUCOMA
17%
STOMATITIS
17%
CHILLS
17%
FOLLICULITIS
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
624 Total Patients Enrolled
AmbrxStudy DirectorAmbrx, Inc.
2 Previous Clinical Trials
293 Total Patients Enrolled

Media Library

ARX788 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03255070 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ARX788 been officially sanctioned by the FDA?

"There is scant evidence of its safety and efficacy, so ARX788 received a score of 1."

Answered by AI

In what areas is this research opportunity accessible?

"Currently, this medical trial is registering participants at 5 centres across the country. Those closest to you geographically include Cleveland, Santa Monica and Los Angeles, plus 2 other places. Choosing a nearby site minimizes travel demands should you decide to join us in our research effort."

Answered by AI

Is enrollment in this study currently available?

"According to the clinicaltrials.gov database, this medical experiment has stopped recruiting patients for participation; it originally began on March 20th 2018 and was last edited November 3rd 2022. Nevertheless, there are 5153 other trials that remain open for enlistment at present."

Answered by AI

What major goals are investigators hoping to accomplish through this trial?

"According to Ambrx, Inc., the main objective of this 36-month trial is to determine the frequency and severity of adverse events. Secondary objectives involve assessing PK characteristics such as ARX788 AUC, half-life from first infusion until end of study, and response rate based on RECIST 1.1 imaging assessment."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
2018. "A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03255070.
~15 spots leftby Apr 2025
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