REGN3767 for Malignancies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Orlando Health, Inc, Orlando, FL
Malignancies+1 More
REGN3767 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

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Eligible Conditions

  • Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignancies

Study Objectives

This trial is evaluating whether REGN3767 will improve 25 primary outcomes and 19 secondary outcomes in patients with Malignancies. Measurement will happen over the course of Baseline to 28 days.

Baseline to 28 days
Rate of dose limiting toxicities (Dose Escalation Phase)
Baseline to 51 weeks
AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Best overall response based on Lugano criteria (Dose Escalation Phase)
Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)
Best overall response based on irRECIST criteria (Dose Escalation Phase)
Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Disease control rate based on Lugano criteria (Dose Escalation Phase)
Disease control rate based on RECIST criteria (Dose Escalation Phase)
Disease control rate based on irRECIST criteria (Dose Escalation Phase)
Incidence of adverse events (Dose Expansion Phase)
Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase)
Incidence of serious adverse events (Dose Expansion Phase)
Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase)
Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase)
Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase)
Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase)
Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase)
Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Occurrence of death (Dose Escalation Phase)
Progression free survival based on Lugano criteria (Dose Escalation Phase)
Progression free survival based on RECIST (Dose Escalation Phase)
Progression free survival based on irRECIST (Dose Escalation Phase)
Rate of adverse events (Dose Escalation Phase)
Rate of serious adverse events (Dose Escalation Phase)
Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to week 51
Duration of response based on Lugano criteria (Dose Escalation Phase)
Duration of response based on RECIST criteria (Dose Escalation Phase)
Duration of response based on irRECIST criteria (Dose Escalation Phase)
Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)
Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)
Month 42
Incidence of death (Dose Expansion Phase)

Trial Safety

Safety Progress

1 of 3

Other trials for Malignancies

Trial Design

2 Treatment Groups

Combination Therapy (REGN3767+cemiplimab)
1 of 2
Monotherapy (REGN3767)
1 of 2
Experimental Treatment

This trial requires 669 total participants across 2 different treatment groups

This trial involves 2 different treatments. REGN3767 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Combination Therapy (REGN3767+cemiplimab)Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion
Monotherapy (REGN3767)
Drug
Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months for reporting.

Closest Location

Orlando Health, Inc - Orlando, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate organ and bone marrow function
Key

Patient Q&A Section

Is regn3767 safe for people?

"Regn3767 is safe in the setting of the treatment that we tested for it. Side effects for people with lung cancer and people undergoing chemotherapy may not be associated with Regn3767 as much as those undergoing surgery. There does not seem to be an increased risk of secondary malignancies in patients with lung cancer or people undergoing chemotherapy who are given Regn3767. Recent findings may help guide treatment in future." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Signs of cancer can include weight loss or increase, itchiness, increased urination, increased sweating, redness and itchiness on the skin. Signs that involve lymph nodes include enlargement of the lymph nodes. Signs of bone cancer involve the symptoms of bone tenderness, warmth, and pain that occur in a single site in the body. Signs of skin cancer include itching, a lump in the skin, or a change in color, shape or size to the skin. Other signs of cancer include changes in bowel habits such as constipation, diarrhoea or abdominal pain or discomfort." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"While some cancers are curable to a great extent, most cancers cannot be cured. But even the curable cancers do better than the non-curable cancer depending on the stage at the time of diagnosis as well as in the number of metastasis and relapse, since patients with non-curable cancer of primary site have a high risk of recurrence compared to patients with curable cancer of primary site." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a disease of the cells of the body. It may be benign (cancer that has not spread), premalignant (cancer that can spread), or malignant (cancer that has already spread). Cancer often appears as tumours, often in the digestive system or respiratory tracts. Some cancers cause no symptoms or cause symptoms that are easy to manage. Others are deadly.\n" - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Approximately 250,000 cases of cancer are diagnosed in the United States each year, making it the most common form of malignancy in men and women." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"The cause and risk factors for cancer are uncertain, although tobacco smoking, in particular, has been linked with cancer in several studies. However, there are many other possible and known environmental risks that impact the development of cancer, including radiation exposure, infections, alcohol and drug use, obesity and metabolic abnormalities. Some types of cancer are associated with genetic predisposition which is sometimes influenced by lifestyle factors. The causes and risk factors for many cancers are not known.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Cancer patients often receive many different types of therapy to address individual symptoms and to improve cancer-specific symptoms, which includes chemotherapy, anti-cancer medications, and radiation therapy. Many cancer treatments also enhance quality of life. This may include use of adjuvants and cancer drugs to reduce or prolong life." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving regn3767?

"In this investigation, there was no evidence to support the use of regn3767 as an additional treatment and there was no clear benefit in terms of overall survival or progression-free time in patients with advanced non small cell lung cancer (NSCLC-NSMC) who were on first line paclitaxel, carboplatin and etoposide chemotherapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer?

"In the past 3 years we have been able to identify several compounds that are being tested very soon in a Phase III clinical trial. These drugs may help patients with cancer in the future. If successful, this research will be the first large randomized trial that is looking at the safety and effectiveness of a novel cancer treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"The average age people in the general population develop cancer is 55 years. The mean age people who are diagnosed with cancer is 73 years. Women are diagnosed much earlier than men, especially in the United States. The highest age diagnosed with cancer was in the US was 85 years in 2012, a person diagnosed in the UK in 2014 was 80 years, whereas in Canada and Australia they were 79 and 77 respectively.\n\nThe age people were diagnosed with the highest cancer rates, is not only what is expected it is what we expect to happen." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of regn3767?

"The most common side effects for gremlinvastatin in clinical trials were gastrointestinal related (nausea, vomiting, diarrhoea) and were generally transient and tolerable in most cases. There are no clinically significant changes in laboratory parameters or in ECG." - Anonymous Online Contributor

Unverified Answer

Does regn3767 improve quality of life for those with cancer?

"RGN-3767 may be a drug with an effect on QoL in patients with advanced cancer. The treatment does not affect PFS or overall OS, but does cause some degree of discomfort and an increase in BUN at end of treatment, which could have a negative impact on QoL in patients with high BUN levels. However, these findings need confirmation in larger and longer studies." - 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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