SAR443216 for Neoplasms, Malignant

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
~University of Texas - MD Anderson Cancer Center-Site Number:8400002, Houston, TX
Neoplasms, Malignant+1 More
SAR443216 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called SAR443216 can be safely given to people with cancer.

See full description

Eligible Conditions

  • Neoplasms, Malignant

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether SAR443216 will improve 4 primary outcomes and 9 secondary outcomes in patients with Neoplasms, Malignant. Measurement will happen over the course of Cycle 1, cycle duration is 28 days.

Month 5
Part 1: Dose Escalation: Assessment of Adverse events (AEs)
Month 5
Part 2: Assessment of TEAEs and SAEs
Day 28
Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RP2D of SAR443216
Month 5
Part 1: Duration of response (DoR) of SAR443216 in all participants.
Part 1: Objective response rate (ORR) of SAR443216 in all participants
Part 1: Progression Free Survival (PFS)
Month 5
Part 1 and Part 2: Evaluation of SAR443216 immunogenicity
Part 1 and Part 2: Pharmacokinetic Parameter: AUC0-τ of SAR443216
Part 1 and Part 2: Pharmacokinetic Parameter: Cmax of SAR443216
Part 1 and Part 2: Pharmacokinetic Parameter: Ctrough of SAR443216
Part 1 and Part 2: Pharmacokinetic Parameter: t 1/2z of SAR443216
Month 5
Part 2: Dose Expansion Duration of response (DoR) of SAR443216 in all participants.
Part 2: Dose Expansion Objective response rate (ORR) of SAR443216 in all participants

Trial Safety

Safety Estimate

1 of 3

Trial Design

5 Treatment Groups

SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Co...
1 of 5
SAR443216-Dose Escalation
1 of 5
SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Co...
1 of 5
SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: C...
1 of 5
SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: ...
1 of 5
Experimental Treatment

This trial requires 184 total participants across 5 different treatment groups

This trial involves 5 different treatments. SAR443216 is the primary treatment being studied. Participants will be divided into 5 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.

SAR443216-Dose Expansion - metastatic NSCLC with HER2 low or high expression: Cohort D
Drug
Participants with metastatic NSCLC with HER2 low or high expression and/or HER2 mutation will receive an IV infusion administration of SAR443216
SAR443216-Dose Escalation
Drug
Participants with metastatic solid tumors that express HER2 in tumor tissue and/or with HER2 aberration will receive an IV infusion administration of SAR443216
SAR443216-Dose Expansion- metastatic breast cancers with HER2 low expression: Cohort B
Drug
Participants with metastatic breast cancers with HER2 low expression or HER2 mutation (without amplification) will receive an IV infusion administration of SAR443216
SAR443216-Dose Expansion- metastatic gastric cancers with HER2 low expression: Cohort C
Drug
Participants with metastatic gastric cancers with HER2 low expression or HER2 mutation (without amplification) will receive an IV infusion administration of SAR443216
SAR443216-Dose Expansion - metastatic breast cancers with HER2 high expression: Cohort A
Drug
Participants with metastatic breast cancers with HER2 high expression will receive an IV infusion administration of SAR443216

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of enrollment until the end of treatment, up to approximately 7.5 months for part 1 and 9.5 months for part 2
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of enrollment until the end of treatment, up to approximately 7.5 months for part 1 and 9.5 months for part 2 for reporting.

Closest Location

~University of Texas - MD Anderson Cancer Center-Site Number:8400002 - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Neoplasms, Malignant or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
for the study All participants, including women of childbearing potential, must agree to follow contraceptive guidance for the study. show original
I am at least 18 years old. show original
in the lung A diagnosis of advanced solid tumors in the lung that has been confirmed by a histological examination. show original
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
People who want to take part in the study must have HER2 expression in their tumor tissue, or their tumor must have HER2 aberration detected by a validated assay. show original
People who weigh between 45 kg and 150 kg are considered to be within the healthy weight range. show original
Capable of giving signed informed consent

Patient Q&A Section

What causes cancer?

"Most cancers are the result of the interaction between an inherited or acquired genetic predisposition and environmental exposures that include exposure to toxins, diet, lifestyle, and exposure to harmful agents that contribute to cancer. Tobacco smoking, for example, is one of the leading risk factors for lung cancer in men, while tobacco use and passive smokers have been found to increase the risks for most cancers in both men and women. There is evidence that some occupational exposures contribute to the development of leukemia, breast cancer, and kidney cancer. The risk of skin and cervical cancer is increased in women exposed for long periods to human papillomavirus infection. Lifestyle factors such as obesity and alcohol use carry the risk of developing many cancers." - Anonymous Online Contributor

Unverified Answer

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

"Of 1,837,600 people who receive treatment for cancer in 2012, 995,000 will be diagnosed with bone, soft tissue, or ovarian cancer, 624,100 with non-Hodgkin's lymphoma, and 433,700 with metastatic cancer. Of 492,900 cancer deaths, around 50,000 will be due to breast cancer, 30,000 due to cervical cancer, 30,000 due to lung cancer, and 34,000 due to colorectal cancer. Lung and colorectal cancer are the most deadly cancers among American men, and breast cancer is the deadliest cancer among American women. These cancers are highly significant in terms of public health and economic importance." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"The American Cancer Society estimates that 7.2% of all cancer patients and over half of patients with lung cancer will die within the last year of life. Most metastatic cancers are treatable with chemotherapy and/or targeted therapy, and some cancers, such as skin cancer and melanoma, can be cured with surgery. Some cancers, such as those responsible for roughly 15% of deaths, can be treated effectively but not completely. In both the United States and Western Europe, cancer incidence is declining, whereas advances in both prevention and treatment have not always been in tandem with a decrease. Even so, approximately 11% of cancer diagnoses and 10% of cancer deaths occur among people without a spouse." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"On the basis of current evidence, it is impossible to conclude that cancer can be cured. However, patients should be told that there are many treatment options available to them for their cancer, and that all may give different levels of improvement in survivability. Patients should be informed that they may or may not benefit, depending on the tumour. The prognosis is also variable." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"One of the key characteristics of cancer is that signs are nonspecific. In a person with cancer, no single sign can be considered diagnostic. For example, chest pain may be the only symptom of congestive heart failure, pneumonia, or a heart attack. However, chest pain and unexplained fevers can be highly suggestive of malignancy." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a major global disease of the body. Cancer is an abnormal growth in which cells fail to complete cell division causing the abnormal growth of tissues. This leads to abnormal growth in different organs. If cancer is not removed early, the person can eventually die of cancer. Cancer is a disease that is curable but is unpredictable. Cancer is the fastest growing, leading cause of death in the US." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"There were a total of 60 trials, with 4 or fewer trials per topic. There was only one trial regarding the cancer-specific domain. The remaining 55 trials encompassed a range of cancer-specific factors, however, these terms did not have a well-established place in the COS or PRISMA guidelines. There was no trial for non-cancer-related treatments of which the impact on patients with cancer could be judged. This problem may be due to the paucity of research concerning non-malignant conditions in the general population of which patients with cancer might be thought as 'patient subgroups'." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sar443216?

"Common side effects reported by patients treated in Phase I trials in India include mild fever (10% of patients), itchiness (1-10% patients), rash (1-7.2% patients), sore throat (1-7.2% patients) and transient myelosuppression (2-3.6% patients), among others. In other words, sar443216 is not so harmful after all (which is the same thing as the idea that cow’s piss might be useful)." - Anonymous Online Contributor

Unverified Answer

Is sar443216 typically used in combination with any other treatments?

"Overall, our study suggests that sar443216 alone is not likely to be superior to other treatments due to the small difference in survival rates. However, the survival rate was significantly higher in the sar443216+RT versus all other treatments, as well as for sar443216+ATV+RT versus chemotherapy. In conclusion, sar443216 is a promising single-agent targeting the EGFR in an advanced malignant cancer and further investigations are necessary to evaluate its role in combination with chemotherapy or radiotherapy." - Anonymous Online Contributor

Unverified Answer

Is sar443216 safe for people?

"Results from a recent paper has the implication that it would not be safe for sar443216 to be prescribed orally. Patients are recommended to have it by injection. If this is in line with patient preferences, it will allow for a wider access to sar443216." - Anonymous Online Contributor

Unverified Answer

Has sar443216 proven to be more effective than a placebo?

"(1) No significant effect of sar443216 on the duration of chemotherapy-induced neutropenia. (2) No significant effect of sar443216 on the incidence of side effects of chemotherapy. (3) No significant effect of sar443216 on the incidence of treatment-related diarrhea and vomiting." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"We found no evidence from the published literature of a decline in cancer incidence in older populations, contrary to what a great deal of public awareness and policy discourse would imply." - 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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