What is being investigated in this study?

Ovarian cancer is often difficult to treat, especially if it recurs after chemotherapy with platinum-based drugs (e.g. carboplatin) or has become insensitive to this treatment. Such cases are referred to as platinum-resistant ovarian cancer.

Researchers have discovered that a specific protein – claudin-6 (CLDN6) – is present in large quantities in many of these tumors. This protein is normally only present in very early stages of cell development and is rarely found in healthy tissue. CLDN6 is therefore considered a promising target for specifically attacking tumor cells without severely damaging healthy tissue.

TORL-1-23 is a so-called antibody-drug conjugate (ADC). This means that this drug consists of an antibody that specifically recognizes and binds CLDN6 proteins on the tumour cell. An active substance is coupled to the antibody, which is introduced into the tumor cell and can destroy the cancer cell there.

An earlier phase 1 trial has already shown that TORL-1-23 was well tolerated and can be active against tumors with CLDN6 expression. The CATALINA-2 trial is now investigating how effective and safe the drug is in a larger group of patients.

What is the aim of the study?

The main aim of the study is to find out how well TORL-1-23 as the sole therapy (monotherapy) delays the progression of the disease and how long patients benefit from the treatment.
In addition, the study will investigate which dosage works best and is also well tolerated.

What is the survey procedure?

The CATALINA-2 study consists of two sections:

• Part 1 (Dose finding):
  This section examines which dose of TORL-1-23 shows the best combination of efficacy and tolerability. For this purpose, doses in three different arms are examined (allocation to one of the arms is randomized):

Arm 1: 2.4 mg TORL-1-23
Arm 2: 3.0 mg TORL-1-23
Arm 3: 3.4 mg TORL-1-23

• Part 2 (efficacy testing):
  TORL-1-23 is tested in a larger group of patients with the dosage determined in Part 1.

Are there any risks?

You will be informed about possible risks and side effects associated with participation during an information session.

Participation requirements

Women aged 18 and over can take part in this study, with:

• Diagnosis of advanced or metastatic, high grade ovarian, fallopian tube or primary peritoneal cancer not responding to platinum-based therapies
• Proven formation of claudin-6 on the surface of the tumor (central laboratory test as part of the study)
• Proven presence of residual tumor at study entry

However, there are also other criteria that must be met in order to participate in the study. Interested patients should speak to the investigators at a study center, who can check whether this study is suitable for them.