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mRNA-2752 for Dose Escalation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alfred Health, Melbourne, AustraliaDose Escalation+1 MoremRNA-2752 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how well a new drug works in people with cancer that has returned or does not respond to treatment.

Eligible Conditions
  • Dose Escalation for Relapsed/Refractory Solid Tumor Malignancies or Lymphoma
  • Immune Checkpoint Refractory Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
LY3410738
1
Dose Escalation: Schedule B
1
VP301 (Dose Escalation)

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Day 180
Overall Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
Day 28
Protein Expression of IL-23, IL-36γ, and OX40L in Tumors
Hour 168
Pharmacokinetics: Maximum Observed Concentration (Cmax)
Up to 2 years
Arm B: Overall Response Rate (ORR): Percentage of Participants with Tumor Response (Partial or Complete) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) in Cutaneous Melanoma
ORR: Percentage of Participants with Tumor Response (Partial or Complete) Based on RECIST v1.1 and modified RECIST (iRECIST), and Cheson and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) for Participants With Lymphoma
Up to 9 months
Number of Participants with Adverse Events (AEs)
Up to Day 28
Number of Participants with Dose Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
LY3410738
1
Dose Escalation: Schedule B
1
VP301 (Dose Escalation)

Side Effects for

Durvalumab
26%Asthenia
20%Anaemia
20%Constipation
17%Decreased appetite
16%Diarrhoea
15%Nausea
13%Pruritus
10%Fatigue
10%Urinary tract infection
10%Cough
9%Vomiting
9%Oedema peripheral
9%Dyspnoea
9%Back pain
9%Pyrexia
7%Abdominal pain
7%Arthralgia
7%Hypothyroidism
7%Haematuria
6%Blood creatinine increased
5%Weight decreased
2%Sepsis
1%Pyelonephritis
1%Acute kidney injury
1%General physical health deterioration
1%Device related infection
1%Death
1%Tumour hyperprogression
1%Urosepsis
1%Pneumonia
1%Pulmonary embolism
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03084471) in the Durvalumab ARM group. Side effects include: Asthenia with 26%, Anaemia with 20%, Constipation with 20%, Decreased appetite with 17%, Diarrhoea with 16%.

Trial Design

3 Treatment Groups

Arm A: mRNA-2752
1 of 3
Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab
1 of 3
Arm B: mRNA-2752 + Durvalumab
1 of 3

Experimental Treatment

264 Total Participants · 3 Treatment Groups

Primary Treatment: mRNA-2752 · No Placebo Group · Phase 1

Arm A: mRNA-2752
Biological
Experimental Group · 1 Intervention: mRNA-2752 · Intervention Types: Biological
Arm C: mRNA-2752 Alone or mRNA-2752 + DurvalumabExperimental Group · 2 Interventions: mRNA-2752, Durvalumab · Intervention Types: Biological, Biological
Arm B: mRNA-2752 + DurvalumabExperimental Group · 2 Interventions: mRNA-2752, Durvalumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,290,756 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,020 Previous Clinical Trials
240,381,172 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You should have a normal thyroid function. However, if you have hypothyroidism that is being treated with medication and is under control, you can still participate in the study.
You have advanced cancer that has not responded to standard treatments or you cannot tolerate those treatments. You have the option to refuse standard treatment.
You have normal blood counts and organ function.
References

Frequently Asked Questions

Has the FDA given their blessing to mRNA-2752?

"So far, mRNA-2752 has only been minimally tested for safety and efficacy, thus earning a score of 1." - Anonymous Online Contributor

Unverified Answer

What illnesses does mRNA-2752 typically target?

"mRNA-2752 is widely employed to treat unresectable stage III non-small cell lung cancer, as well as previously untreated metastatic urothelial carcinoma and advanced directives." - Anonymous Online Contributor

Unverified Answer

Are there any locales currently administering this research project within city boundaries?

"The Sarah Cannon Research Institute in Nashville, the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, and Yale Cancer Center in New Haven are some of the 15 active sites for this study. Other locations also exist which qualify for enrolment." - Anonymous Online Contributor

Unverified Answer

What is the scope of participants in this clinical exploration?

"AstraZeneca, the sponsor of this trial, needs to recruit 264 candidates that meet their set inclusion criteria. These patients will be sourced from multiple medical centres including Sarah Cannon Research Institute in Nashville and UCSF Helen Diller Family Comprehensive Cancer Center located in San Francisco." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available for individuals to partake in this research?

"Affirmative. Clinicaltrials.gov states that, as of July 14th 2022, this research is actively enrolling 264 patients across 15 medical facilities. The trial was initially posted on November 27th 2018 and has been modified since then." - Anonymous Online Contributor

Unverified Answer

Are there any prior investigations involving mRNA-2752 that have been documented?

"Currently, 333 clinical trials are underway studying the effects of mRNA-2752 with 52 studies at Phase 3. Most locations for these trials are located in Cordoba, Texas; however, this medication is being trialed across 12961 centers globally." - 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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