All > Her 2 Positive Breast Cancer > Gastric Cancer

ARX788 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OHBreast Cancer+2 MoreARX788 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 36 months

18 months
Number of subjects with tumor response per imaging assessment based on RECIST version 1.1.
36 months
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
Phase 1b: Objective response rate (ORR: complete response + partial response) per imaging assessment based on RECIST version 1.1.
Day 30
Number of subjects experiencing adverse events, frequency and seriousness of treatment emergent adverse events (TEAEs)

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Arm E (Phase II Expansion): Pola+BG in FL
65%FATIGUE
55%NAUSEA
50%DIARRHOEA
40%VOMITING
35%CONSTIPATION
35%DYSPNOEA
30%NEUTROPENIA
30%DECREASED APPETITE
30%HEADACHE
25%UPPER RESPIRATORY TRACT INFECTION
25%NEUROPATHY PERIPHERAL
20%HYPOMAGNESAEMIA
20%THROMBOCYTOPENIA
15%ALOPECIA
15%PRODUCTIVE COUGH
15%DYSGEUSIA
15%BLOOD CREATININE INCREASED
15%ANAEMIA
15%DRY MOUTH
15%DYSPEPSIA
15%WHITE BLOOD CELL COUNT DECREASED
15%HYPOKALAEMIA
15%BACK PAIN
15%MUSCULAR WEAKNESS
15%DIZZINESS
15%PERIPHERAL SENSORY NEUROPATHY
15%RASH
10%NASAL CONGESTION
10%DEPRESSION
10%COUGH
10%INSOMNIA
10%DYSURIA
10%URINARY TRACT INFECTION
10%FEBRILE NEUTROPENIA
10%ALANINE AMINOTRANSFERASE INCREASED
10%ASPARTATE AMINOTRANSFERASE INCREASED
10%BLOOD ALKALINE PHOSPHATASE INCREASED
10%BLOOD BILIRUBIN INCREASED
10%LYMPHOPENIA
10%FLATULENCE
10%GASTROOESOPHAGEAL REFLUX DISEASE
10%CHILLS
10%MUCOSAL INFLAMMATION
10%OEDEMA PERIPHERAL
10%PYREXIA
10%HERPES VIRUS INFECTION
10%SINUSITIS
10%LYMPHOCYTE COUNT DECREASED
10%WEIGHT DECREASED
10%HYPERURICAEMIA
10%HYPOCALCAEMIA
10%HYPOPHOSPHATAEMIA
10%ARTHRALGIA
10%HYPOAESTHESIA
10%PERIPHERAL MOTOR NEUROPATHY
10%DYSPHONIA
10%UPPER-AIRWAY COUGH SYNDROME
10%OROPHARYNGEAL PAIN
10%FLUSHING
5%ANAL SPASM
5%HAEMOLYTIC ANAEMIA
5%PARONYCHIA
5%LIP DRY
5%EYE PRURITUS
5%HYPONATRAEMIA
5%DEHYDRATION
5%ACUTE KIDNEY INJURY
5%VISION BLURRED
5%PARAESTHESIA
5%INFUSION RELATED REACTION
5%LEUKOPENIA
5%LIPASE INCREASED
5%INFECTION
5%OESOPHAGEAL CANDIDIASIS
5%PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
5%SEIZURE
5%ACUTE PULMONARY OEDEMA
5%HYPOXIA
5%ABDOMINAL DISTENSION
5%STOMATITIS
5%PAIN
5%HYPOGAMMAGLOBULINAEMIA
5%HERPES ZOSTER
5%PNEUMONIA
5%PLATELET COUNT DECREASED
5%HYPERGLYCAEMIA
5%HYPOALBUMINAEMIA
5%PAIN IN EXTREMITY
5%POST HERPETIC NEURALGIA
5%ANXIETY
5%POLLAKIURIA
5%DYSPNOEA EXERTIONAL
5%RHINORRHOEA
5%PRURITUS
5%RASH MACULO-PAPULAR
5%HYPERTENSION
5%HAEMOLYSIS
5%LYMPHADENOPATHY
5%SINUS TACHYCARDIA
5%ABDOMINAL DISCOMFORT
5%DEFAECATION URGENCY
5%GINGIVAL DISORDER
5%GINGIVAL PAIN
5%HAEMATOCHEZIA
5%HAEMORRHOIDS
5%HYPERSENSITIVITY
5%ESCHERICHIA URINARY TRACT INFECTION
5%LOWER RESPIRATORY TRACT INFECTION
5%ORAL CANDIDIASIS
5%COMMINUTED FRACTURE
5%WOUND
5%TROPONIN I INCREASED
5%HYPOGLYCAEMIA
5%CERVICAL SPINAL STENOSIS
5%INTERVERTEBRAL DISC DEGENERATION
5%MUSCULOSKELETAL STIFFNESS
5%TUMOUR PAIN
5%LETHARGY
5%NEURALGIA
5%SINUS HEADACHE
5%IRRITABILITY
5%MENTAL STATUS CHANGES
5%URINARY RETENTION
5%VAGINAL DISCHARGE
5%PULMONARY OEDEMA
5%SINUS PAIN
5%DERMATITIS
5%RASH MACULAR
5%EMBOLISM
5%ENDOMETRIAL ADENOCARCINOMA
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02257567) in the Arm E (Phase II Expansion): Pola+BG in FL ARM group. Side effects include: FATIGUE with 65%, NAUSEA with 55%, DIARRHOEA with 50%, VOMITING with 40%, CONSTIPATION with 35%.

Trial Design

2 Treatment Groups

ARX788 Phase 1b (Dose Expansion)
1 of 2
ARX788 Phase 1a (Dose Escalation)
1 of 2

Experimental Treatment

106 Total Participants · 2 Treatment Groups

Primary Treatment: ARX788 · No Placebo Group · Phase 1

ARX788 Phase 1b (Dose Expansion)
Drug
Experimental Group · 1 Intervention: ARX788 · Intervention Types: Drug
ARX788 Phase 1a (Dose Escalation)
Drug
Experimental Group · 1 Intervention: ARX788 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Ambrx, Inc.Lead Sponsor
6 Previous Clinical Trials
402 Total Patients Enrolled
AmbrxStudy DirectorAmbrx, Inc.
2 Previous Clinical Trials
107 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Has ARX788 been officially sanctioned by the FDA?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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