New clinical trial BNT152+153.

[kklott01]

Hi, I'm about to enter into a new Phase 1 clinical trial at MD Anderson for solid tumors including new drugs from BioNtech called BNT152+153, which are based on Interluekin 2 & 7.

Do any members have any knowledge or experience with these relatively new trial drugs?

There is an NCT listing on the clinicaltrial.gov site but it has only nominal information.

Trying to understand more about potential side effects. Thanks!

[MyDad76]

I don’t have sny information but I wish you best of luck. And please keep us updated!

[swwags]

Google is your friend here - this is the trial - It's a phase one study so the goal is to find a safe dosage before moving on to phase 2 which is effectiveness.

This is the official description - scroll down to see it in layman's terms

This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and

pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications.

The clinical trial will enroll patients with various solid tumors that are metastatic or

unresectable for whom there is no available standard therapy likely to confer clinical

benefit, or patients who are not candidates for such available therapy.

The trial consists of Part 1 and Part 2 with adaptive design elements:

- Part 1 consists of Groups A and B.

- Group A is a BNT153 monotherapy dose escalation in patients with advanced solid

malignancies until the maximal tolerated dose (MTD) is defined. If MTD is not

reached, maximum administered dose (MAD) may be used for further development (or

another dose as determined by the safety review committee [SRC]).

- Group B is a BNT152 monotherapy dose escalation in patients with advanced solid

malignancies until the MTD or optimal biological dose (OBD; the lowest safe dose

associated with optimal biological activity) is defined, whichever occurs earlier.

- Group A will be activated first while the time point for Group B activation is at

sponsor's decision.

- Part 2 will start after the MTD or MAD or another dose as determined by the SRC have

been established for BNT153 and MTD or OBD for BNT152 in Part 1. Part 2 (Part 2A, 2B and

2C) is a dose escalation of BNT152+153 in patients with advanced solid malignancies

until the recommended Phase II dose (RP2D) is defined.

- Part 2 may implement a biomarker cohort if a clinical benefit is observed at one or more

doses of BNT152+153 that show a clear PD effect in the peripheral blood. The Biomarker

Cohort will recruit patients at selected sites.

And here it is explained in layman's terms:

This is a scientific study to test a new treatment called BNT152+153 on people with various advanced cancers. The goal is to find out if it's safe, how the body processes it, and how it affects the tumors.

The study has two parts:

Part 1:

Group A: Testing BNT153 alone on patients until they figure out the highest dose the patients can tolerate (maximal tolerated dose or MTD).

Group B: Testing BNT152 alone on patients until they find the highest safe dose or the optimal biological dose (OBD) that gives the best effect.

They'll start with Group A and, if everything goes well, move on to Group B.

Part 2:

This part begins after they've determined the best doses from Part 1.

Part 2A, 2B, and 2C: Combining BNT152 and BNT153 in different doses and giving it to patients until they find the right dose for the next phase of testing (recommended Phase II dose or RP2D).

If they see positive effects in the blood at certain doses, they might create a special group (Biomarker Cohort) for patients showing these effects.

The goal is to learn if this new treatment works and is safe for people with advanced cancers who don't have other good treatment options. The study is split into parts to carefully figure out the right doses to use in future studies.

[kklott01 in reply to swwags]

Swags, thank you for providing the details. I've read the details from the NCT listing as well as what MD Anderson posted internally. What I was attempting to learn was if anyone in the forum might also be a participant in this trial, anywhere in the world.

This is trial number 5 for me overall and number 2 in a Phase 1. Side effects and quality of life are a huge deal for me, so I'm interested to obtain any/all real world experiences from brothers who won't sugar coat what they are dealing with.

[tango65]

These drugs stimulate the production of interleukins 2 and 7. Check in Google about the actions of these interleukins in the body.

[Llcoleman]

I know nothing about your trial, but my husband participated in a trial for 18 months at MD Anderson with Dr. Dumbrava. We could not have been more pleased with the care and attention he received. Wishing you the best!

[j-o-h-n]

Hello kk, you may want to correct your spelling in your post to "Interleukin" and not Interluekin - you transposed the letters u e and should be e u.

Had a hard time searching history, but eventually found this post from 11 months ago.

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tayninhtom•

11 months ago•1 Reply

Has anyone heard of this new research? Uses interleukin-2 (IL-2) to destroy cancer cells in 6 days.

aacrjournals.org/clincancer...

Quickly kills cancer cells in mice. Don't think human trials have begun.

Male77 years old United States

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Good Luck, Good Health and Good Health.

j-o-h-n Saturday 11/11/2023 2:11 PM DST - Honor our Veterans.

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