A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax® -TF -ADC) Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination
with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB
cervical cancer.

The trial consists of two-parts a dose escalation part and an expansion part. The expansion
part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the
combinations have been determined in the dose escalation part.

Inclusion Criteria:

- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on
or after standard of care treatments or are ineligible or intolerant to standard of
care for recurrent or stage IVB cervical cancer (Arms A, B and C only).

- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have
received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E,
and H only).

- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on
or after at least one but no more than two prior systemic therapies for recurrent or
stage IVB cervical cancer (Arms F and G only).

- Must have baseline measurable disease per RECIST v1.1.

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All
Arms).

- Is not pregnant, breastfeeding, or expecting to conceive children within the projected
duration of the trial and for at least 6 months after the last trial treatment
administration

- Participants of childbearing potential must agree to use adequate contraception during
and for 6 months after the last dose of trial treatment administration.

- Must sign an informed consent form (ICF) indicating the trial subject understands the
purpose of and procedures required for the trial and are willing to participate in the
trial (All Arms).

Exclusion Criteria:

- Has clinically relevant bilateral hydronephrosis which cannot be alleviated by
ureteral stents or percutaneous drainage. (All Arms)

- Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral
hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal
surgery are permitted. (All Arms)

- Has clinically significant bleeding issues or risks

- Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon
or more) (Arm A and bevacizumab-eligible participants in Arm H)

- Recent (within 4 weeks of first dose of trial treatment) clinically significant
gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H
only)

- Recent (within 4 weeks of first dose of trial treatment) evidence of wound
healing complications that require medical intervention (Arms A and H only)

- Has active ocular surface disease at baseline. Subjects with prior history of
cicatricial conjunctivitis are ineligible (All Arms).

- Clinically significant cardiac disease

- Requires anti-coagulation therapy (Arms A and H only)