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Monoclonal Antibodies

ASP3082 for Cancer

Phase 1
Recruiting
Research Sponsored by Astellas Pharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 6 months after study intervention administration.
Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent [defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone] is permitted), and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<= 2 weeks of radiotherapy) to non-central nervous system disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, ASP3082, to see if it is safe and effective in treating people with certain solid tumors.

Who is the study for?
Adults with advanced solid tumors that can't be removed by surgery or have spread, and who have a specific mutation (KRAS G12D) after standard treatments or refusal of such therapies. They must be in good physical condition, not pregnant, agree to contraception use, and have recovered from previous treatment side effects.Check my eligibility
What is being tested?
The trial is testing ASP3082 alone and combined with cetuximab in adults with certain solid tumors having the KRAS G12D mutation. It's an open-label study where participants know what they're receiving. The goal is to determine safe dosages and monitor how well patients tolerate the treatments over multiple cycles.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to cancer medications like infusion-related discomfort, organ inflammation, fatigue, digestive issues, blood disorders, increased infection risk as well as any adverse events observed during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will not donate eggs during and for 6 months after the study.
Select...
I finished any radiotherapy 14 days ago, have no side effects, and don't need steroids.
Select...
It's been over 21 days or 5 half-lives since my last cancer treatment before starting the study.
Select...
I agree not to breastfeed during and for 6 months after the study.
Select...
I can care for myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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
Incidence of Dose Limiting Toxicities (DLTs)
Number of Participants with Adverse Events (AEs)
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status
+5 more
Secondary outcome measures
Changes in Kirsten rat sarcoma (KRAS) viral oncogene homolog G12D in tumor samples
Disease Control Rate (DCR) per RECIST v 1.1
Duration of Response (DOR) per RECIST v 1.1
+5 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Insomnia
18%
Non-cardiac chest pain
18%
Aspartate aminotransferase increased
18%
Alkaline phosphatase increased
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Arthralgia
10%
Dizziness
10%
Edema limbs
8%
Oral dysesthesia
8%
Anxiety
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Vertigo
3%
Alopecia
3%
Tracheostomy site bleeding
3%
Oral pain
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Trial Design

5Treatment groups
Experimental Treatment
Group I: ASP3082 Dose Expansion (Monotherapy Part 2)Experimental Treatment1 Intervention
Participants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.
Group II: ASP3082 Dose Escalation (Monotherapy Part 1)Experimental Treatment1 Intervention
Participants will receive ASP3082 in a 21-day cycle.
Group III: ASP3082 China Safety CohortExperimental Treatment1 Intervention
Participants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.
Group IV: ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)Experimental Treatment2 Interventions
Participants with locally advanced or metastatic colorectal cancer will receive ASP3082 or ASP3082 + Cetuximab with dose level(s) selected from dose escalation (part 1) in a 21-day cycle. Cetuximab will be administered weekly.
Group V: ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)Experimental Treatment2 Interventions
Participants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Astellas Pharma IncLead Sponsor
689 Previous Clinical Trials
219,683 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Inc
2,770 Previous Clinical Trials
8,061,770 Total Patients Enrolled

Media Library

ASP3082 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05382559 — Phase 1
Solid Tumors Research Study Groups: ASP3082 Dose Escalation (Monotherapy Part 1), ASP3082 Dose Expansion (Monotherapy Part 2), ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1), ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2), ASP3082 China Safety Cohort
Solid Tumors Clinical Trial 2023: ASP3082 Highlights & Side Effects. Trial Name: NCT05382559 — Phase 1
ASP3082 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05382559 — Phase 1

Frequently Asked Questions

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

What is the overall size of this trial's participant pool?

"To complete this research, 240 qualified individuals have to be recruited from around the country. Specifically, patients can join in at Vanderbilt University Medical Center and Washington University School of Medicine."

Answered by AI

What sort of results is this experiment aiming to accomplish?

"The primary outcome for this medical trial, which is conducted by Astellas Pharma Inc. and will endure up to 48 months, will be the number of participants that experience laboratory value abnormalities or adverse events (AEs). Secondary outcomes include tmax from plasma samples collected as part of pharmacokinetics (PK), disease control rate per RECIST version 1.1 and AUC based on PK plasma sample data collection."

Answered by AI

Where can one find a medical facility that is participating in the trial within this city?

"11 medical centres are currently enrolling patients in this clinical trial. Notable locations include Vanderbilt University Medical Center (Nashville), Washington University School of Medicine (Saint Louis) and Florida Cancer Specialists & Research Institute Sarasota (Sarasota)."

Answered by AI

Has the FDA passed judgement on ASP3082?

"Because of its limited clinical data, ASP3082 received a score of 1 on our safety scale. This trial is currently in Phase 1 and does not yet have sufficient evidence to support efficacy or safety."

Answered by AI

Is there an ongoing call for participants in this experiment?

"According to the information found on clinicaltrials.gov, this experiment is still recruiting participants. It was first posted on June 8th 2022 and its data has been revised most recently on November 17th of the same year."

Answered by AI
~212 spots leftby Oct 2026